101 results on '"Michael J. DePalma"'
Search Results
2. Effect of age on outcomes after allogeneic disc tissue supplementation in patients with chronic discogenic low back pain in the VAST trial
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Corey W Hunter, Richard Guyer, Mark Froimson, and Michael J DePalma
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Adult ,Male ,Age Factors ,Intervertebral Disc Degeneration ,General Medicine ,humanities ,Treatment Outcome ,Humans ,Transplantation, Homologous ,Female ,Chronic Pain ,Intervertebral Disc ,Low Back Pain ,Pain Measurement - Abstract
The VAST trial evaluated a new treatment for patients with chronic back pain resulting from one or two degenerated spinal discs. The treatment consists of a single injection of disc tissue supplement. A total of 218 adults participated in the study; most received the active treatment, while a smaller number (39 patients) received an injection of saline. In this paper we explain what happened over the 12 months after the injections. Patients who were younger (42 years old) experienced more functional benefits (i.e., ability to perform daily tasks) after active treatment compared with those who received the saline injection, as measured by disability score. In contrast, older patients (≥42 years old) experienced functional benefits with both active and saline treatments, with no differences between the groups. There were more side effects in both age groups in those who received the active treatment compared with those who received saline, but almost all of the side effects were temporary and not serious.
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- 2022
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3. Joints
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Naveen S. Khokhar and Michael J. DePalma
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- 2022
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4. Use of Bone Marrow Concentrate to Treat Pain and Musculoskeletal Disorders: An Academic Delphi Investigation
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R Amadeus Mason, Michael J. DePalma, Ian Stemper, Mairin A Jerome, Sarah M. Pastoriza, Gerard A. Malanga, Ehren Dodson, Christopher J. Centeno, Shane A. Shapiro, and Ken Mautner
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medicine.medical_specialty ,business.industry ,Best practice ,Delphi method ,Evidence-based medicine ,Institutional review board ,Likert scale ,Patient safety ,Anesthesiology and Pain Medicine ,Informed consent ,Family medicine ,Medicine ,business ,Grading (education) - Abstract
Background: Acute and degenerative musculoskeletal disorders are among the most common etiologies of disability worldwide. Recently, there has been interest in the field of regenerative medicine to bridge the gap between conservative and surgical management of these conditions. Autologous bone marrow concentrate is one type of injectate that has increased in popularity over the last few decades. Though there is promising evidence supporting its efficacy, standard of care practice guidelines to govern the appropriate use and implementation of such technology are currently lacking. Objectives: The aim of this article is to report findings from a survey administered using the Delphi technique to a group of physicians using bone marrow concentrate in practice to determine best practice consensus regarding optimization of patient safety and education. Study Design: Delphi panel technique. Setting: The study was first announced at a national meeting and continued remotely across the United States via 4 rounds of online surveys. Methods: An initial panel of 30 expert members was convened and a 5-member steering committee was established. Four rounds of consensus questionnaires totaling 11 unique questions were distributed. Ten questions included a 5-point Likert scale from “Strongly Agree” to “Strongly Disagree,” and one question had a selection of 5 options regarding minimum level of evidence required. The anonymized aggregate results of each round were shared with the group prior to voting in the subsequent round in accordance with the Delphi process. Consensus was defined as 80% agreement of the statements indicating either “Strongly Agree” or “Agree” for the 10 questions with the Likert Scale and 80% agreement among 2 of 5 choices in the question regarding levels of evidence. Results: Three invited participants were excluded by the second round of questions due to lack of response in a timely manner, leaving 27 physicians queried. Nine of the 11 questions met criteria for > 80% consensus. Areas of agreement included importance of a treatment registry, candidacy grading, expanded informed consent, scientific accuracy in advertising, institutional review board approval for novel uses, performance of procedures by only licensed physicians or mid-level providers with direct physician oversight, use of image guidance for injections, data submission for publication in peer reviewed literature, and a minimum requirement of case-series level of evidence for use of bone marrow concentrate in musculoskeletal medicine. The 2 areas that did not meet criteria for consensus included online publishing of individual clinic data and standards around cell counting for dosing. Limitations: The Delphi panel of experts was convened on a voluntary basis rather than a nomination process. Our panel of experts were all physicians who use bone marrow concentrate in practice, therefore it is possible that a different panel of experts within other disciplines would reach different conclusions. Conclusions: There is significant consensus among a panel of physicians performing bone marrow concentrate injections regarding best practice guidelines for musculoskeletal conditions. Key words: Bone marrow concentrate, musculoskeletal, BMC, BMAC, injections, orthopedic, orthobiologic, Delphi method, regenerative medicine, bone marrow aspirate
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- 2021
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5. Percutaneous Peripheral Nerve Stimulation of the Medial Branch Nerves for the Treatment of Chronic Axial Back Pain in Patients After Radiofrequency Ablation
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David A Spinner, Christopher A. Gilmore, Michael J. DePalma, Timothy R. Deer, Sean C Li, Thomas J. Hopkins, Abram H. Burgher, Joseph W. Boggs, Steven P Cohen, Meredith J McGee, and Mehul J. Desai
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medicine.medical_specialty ,Percutaneous ,Radiofrequency ablation ,law.invention ,Lumbar ,law ,Multicenter trial ,medicine ,Back pain ,Preliminary Research Article ,Radiofrequency Ablation ,business.industry ,Chronic pain ,General Medicine ,medicine.disease ,Low back pain ,Neuromodulation (medicine) ,Surgery ,Anesthesiology and Pain Medicine ,Neuromodulation & Interventional Section ,Neurology (clinical) ,Chronic Pain ,medicine.symptom ,AcademicSubjects/MED00010 ,business ,Low Back Pain ,Percutaneous Peripheral Nerve Stimulation - Abstract
Objective Lumbar radiofrequency ablation is a commonly used intervention for chronic back pain. However, the pain typically returns, and though retreatment may be successful, the procedure involves destruction of the medial branch nerves, which denervates the multifidus. Repeated procedures typically have diminishing returns, which can lead to opioid use, surgery, or implantation of permanent neuromodulation systems. The objective of this report is to demonstrate the potential use of percutaneous peripheral nerve stimulation (PNS) as a minimally invasive, nondestructive, motor-sparing alternative to repeat radiofrequency ablation and more invasive surgical procedures. Design Prospective, multicenter trial. Methods Individuals with a return of chronic axial pain after radiofrequency ablation underwent implantation of percutaneous PNS leads targeting the medial branch nerves. Stimulation was delivered for up to 60 days, after which the leads were removed. Participants were followed up to 5 months after the start of PNS. Outcomes included pain intensity, disability, and pain interference. Results Highly clinically significant (≥50%) reductions in average pain intensity were reported by a majority of participants (67%, n = 10/15) after 2 months with PNS, and a majority experienced clinically significant improvements in functional outcomes, as measured by disability (87%, n = 13/15) and pain interference (80%, n = 12/15). Five months after PNS, 93% (n = 14/15) reported clinically meaningful improvement in one or more outcome measures, and a majority experienced clinically meaningful improvements in all three outcomes (i.e., pain intensity, disability, and pain interference). Conclusions Percutaneous PNS has the potential to shift the pain management paradigm by providing an effective, nondestructive, motor-sparing neuromodulation treatment.
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- 2021
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6. Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain
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Jeffrey Lyman, Lynn Kohan, Douglas Beall, Ignacio Badiola, Eric Loudermilk, Maged Guirguis, Antonia F. Chen, Matthew J. Pingree, Fred Khalouf, Michael J. DePalma, and Keith Zora
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Adult ,Male ,WOMAC ,Knee Joint ,Radiofrequency ablation ,Osteoarthritis ,Injections, Intra-Articular ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Quality of life ,Randomized controlled trial ,law ,Hyaluronic acid ,Clinical endpoint ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Hyaluronic Acid ,Adverse effect ,Aged ,Aged, 80 and over ,030203 arthritis & rheumatology ,Radiofrequency Ablation ,Viscosupplements ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Arthralgia ,Cold Temperature ,Treatment Outcome ,chemistry ,Anesthesia ,Female ,Surgery ,Chronic Pain ,business ,030217 neurology & neurosurgery - Abstract
BACKGROUND Knee osteoarthritis is a painful and sometimes debilitating disease that often affects patients for years. Current treatments include short-lasting and often repetitive nonsurgical options, followed by surgical intervention for appropriate candidates. Cooled radiofrequency ablation (CRFA) is a minimally invasive procedure for the treatment of pain related to knee osteoarthritis. This trial compared the efficacy and safety of CRFA with those of a single hyaluronic acid (HA) injection. METHODS Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities were screened for enrollment in this multicenter, randomized trial. One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single HA injection. One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA). Evaluations for pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety were performed at 1, 3, and 6 months after treatment. RESULTS Demographic characteristics did not differ significantly between the 2 study groups. A total of 158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up. In the CRFA group, 71% of the subjects had ≥50% reduction in the NRS pain score (primary end point) compared with 38% in the HA group (p < 0.0001). At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001). The mean WOMAC score improvement at 6 months from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p < 0.0001). At 6 months, 72% of the subjects in the CRFA group reported improvement in the GPE score compared with 40% in the HA group (p < 0.0001). CONCLUSIONS CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of HA. No serious adverse events related to either procedure were noted, and the overall adverse-event profiles were similar. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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- 2020
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7. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study
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Michael J. DePalma, Gregory Moore, Evish Kamrava, Eeric Truumees, David Greg Anderson, Jeffrey S. Fischgrund, Kevin Macadaeg, Alfred L. Rhyne, Douglas Buxton, Philip Yuan, Michael K. Schaufele, Michael Sikorsky, Christopher A. Yeung, and James B. Reynolds
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medicine.medical_specialty ,business.industry ,Radiofrequency ablation ,medicine.medical_treatment ,Modic changes ,Ablation ,law.invention ,Chronic low back pain ,Surgery ,Patient satisfaction ,Randomized controlled trial ,law ,medicine ,Orthopedics and Sports Medicine ,Neurosurgery ,business ,Treatment Arm - Abstract
Background Damaged or degenerated vertebral endplates are a significant cause of vertebrogenic chronic low back pain (CLBP). Modic changes are one objective MRI biomarker for these patients. Prior data from the treatment arm of a sham-controlled, RCT showed maintenance of clinical improvements at 2 years following ablation of the basivertebral nerve (BVN). This study reports 5-year clinical outcomes. Methods In total, 117 US patients were treated successfully with BVN ablation. Patient-reported outcomes of ODI, VAS, postablation treatments, and patient satisfaction were collected at a minimum of 5-years following BVN ablation. Primary outcome was mean change in ODI. Comparisons between the postablation and baseline values were made using an analysis of covariance with alpha 0.05. Results Of the 117 US treated patients 100 (85%) were available for review with a mean follow-up of 6.4 years (5.4–7.8 years). Mean ODI score improved from 42.81 to 16.86 at 5-year follow-up, a reduction of 25.95 points (p p 50% reduction in pain, 47% reported a > 75% reduction in pain, and 34% of patients reported complete pain resolution. Composite responder rate using thresholds of ≥ 15-point ODI and ≥ 2-point VAS for function and pain at 5 years was 75%. Conclusion CLBP patients treated with BVN ablation exhibit sustained clinical improvements in function and pain with high responder rates at a mean of 6.4 years following treatment. BVN ablation is a durable, minimally invasive treatment for vertebrogenic CLBP.
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- 2020
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8. Vertebrogenic Pain: A Paradigm Shift in Diagnosis and Treatment of Axial Low Back Pain
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Aaron Conger, Matthew Smuck, Eeric Truumees, Jeffrey C Lotz, Michael J DePalma, and Zachary L McCormick
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Anesthesiology and Pain Medicine ,Humans ,Neurology (clinical) ,General Medicine ,Low Back Pain ,Intervertebral Disc Displacement - Published
- 2022
9. Durable patient-reported outcomes following 60-day percutaneous peripheral nerve stimulation (PNS) of the medial branch nerves
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Christopher A. Gilmore, Timothy R. Deer, Mehul J. Desai, Thomas J. Hopkins, Sean Li, Michael J. DePalma, Steven P. Cohen, Meredith J. McGee, and Joseph W. Boggs
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- 2023
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10. 40. Disc progenitor cell therapy improves pain, disability, and quality of life for patients with lumbar disc degeneration: results of an FDA-approved clinical trial
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Matthew F Gornet, Douglas P. Beall, Timothy T. Davis, Domagoj Coric, Michael LaBagnara, Angela Krull, Michael J. DePalma, Patrick C. Hsieh, Srinivas Mallempati, and Kevin T. Foley
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Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) - Published
- 2022
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11. Viable Disc Tissue Allograft Supplementation; One- and Two-level Treatment of Degenerated Intervertebral Discs in Patients with Chronic Discogenic Low Back Pain: One Year Results of the VAST Randomized Controlled Trial
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Douglas P, Beall, Timothy, Davis, Michael J, DePalma, Kasra, Amirdelfan, Edward S, Yoon, Gregory L, Wilson, Randolph, Bishop, William C, Tally, Steven L, Gershon, Morgan P, Lorio, Hans Joerg, Meisel, Meredith, Langhorst, Timothy, Ganey, and Corey W, Hunter
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Dietary Supplements ,Humans ,Intervertebral Disc Degeneration ,Allografts ,Intervertebral Disc ,Low Back Pain ,Intervertebral Disc Displacement - Published
- 2021
12. Cooled Radiofrequency Ablation Treatment of the Genicular Nerves in the Treatment of Osteoarthritic Knee Pain: 18‐ and 24‐Month Results
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Tim R.C. Davis, Michael J. DePalma, Corey W. Hunter, Leonardo Kapural, and Eric Loudermilk
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Male ,Steroid injection ,medicine.medical_specialty ,Knee Joint ,Radiofrequency ablation ,Osteoarthritis ,law.invention ,Injections, Intra-Articular ,Time ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,030202 anesthesiology ,law ,Adrenal Cortex Hormones ,medicine ,Humans ,Pain Management ,Osteoarthritic knee ,Prospective Studies ,Aged ,business.industry ,Original Articles ,Middle Aged ,Osteoarthritis, Knee ,medicine.disease ,Anesthesiology and Pain Medicine ,Knee pain ,Treatment Outcome ,Physical therapy ,Catheter Ablation ,Observational study ,Original Article ,Female ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Oxford knee score ,Follow-Up Studies - Abstract
Objective The primary objective of this observational, prospective, multicenter study was to evaluate the long‐term outcomes, including pain, function, and perceived effect of treatment, in subjects undergoing cooled radiofrequency ablation (CRFA) who have pain due to osteoarthritis (OA) of the knee. Methods This analysis included a subset of subjects previously enrolled in a prospective, multicenter randomized study comparing the safety and effectiveness of CRFA and intra‐articular steroid injection in patients with knee OA through 12 months who were contacted to participate in this extension study. Subjects were enrolled if they agreed to participate in up to 2 additional follow‐ups, at 18 and 24 months. Results Eighty‐three subjects from the 5 participating sites underwent CRFA during the original study and were contacted for this extension study. Of the 33 subjects enrolled, 25 were evaluated at 18 months after CRFA treatment, and their mean numeric rating scale (NRS) score was 3.1 ± 2.7, with 12 subjects reporting ≥50% pain relief compared to baseline. At 24 months, 18 subjects reported a mean NRS score of 3.6 ± 2.8, with 11 demonstrating ≥50% pain relief. Functional improvement as measured by the Oxford Knee Score continued to be present, with an overall mean change from baseline of 26.0 ± 9.6 points at 18 months and 29.9 ± 10.4 points at 24 months. Conclusion In this subset of subjects from a randomized controlled trial, CRFA provided sustained pain relief, improved function, and perceived positive effect through 24 months for subjects with OA knee pain with no safety concerns identified.
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- 2019
13. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
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Peter Vajkoczy, Eeric Truumees, Hyun W. Bae, Lee Thibodeau, Alfred L Rhyne, Michael J. DePalma, Jeffrey S. Fischgrund, Michael K. Schaufele, Bernhard Meyer, Christopher Yeung, David Greg Anderson, Jörg Franke, Philip Yuan, Rick C. Sasso, and Scott Kitchel
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medicine.medical_specialty ,business.industry ,Radiofrequency ablation ,Visual analogue scale ,medicine.medical_treatment ,Ablation ,Oswestry Disability Index ,Surgery ,Chronic low back pain ,law.invention ,Double blind ,03 medical and health sciences ,0302 clinical medicine ,Multicenter study ,Randomized controlled trial ,law ,medicine ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,business ,Lumbar Spine ,030217 neurology & neurosurgery - Abstract
Background: The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up. Methods: A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at 2 and 6 weeks, and 3, 6, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes. Results: Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients. Conclusions: Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP.
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- 2019
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14. Treatment of chronic axial back pain with 60-day percutaneous medial branch PNS: Primary end point results from a prospective, multicenter study
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Kasra Amirdelfan, Warren Grace, Mehul J. Desai, Timothy R. Deer, Meredith J McGee, Joseph W. Boggs, Puneet Sayal, Thomas J. Hopkins, Abram H. Burgher, Christopher A. Gilmore, Michael J. DePalma, Steven P. Cohen, and Sean Li
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medicine.medical_specialty ,Percutaneous ,business.industry ,medicine.medical_treatment ,Low back pain ,Surgery ,Anesthesiology and Pain Medicine ,Lumbar ,Treatment Outcome ,Multicenter study ,Back Pain ,medicine ,Clinical endpoint ,Back pain ,Transcutaneous Electric Nerve Stimulation ,Humans ,Prospective Studies ,medicine.symptom ,Lead (electronics) ,business ,Neurostimulation ,Low Back Pain - Abstract
BACKGROUND The objective of this prospective, multicenter study is to characterize responses to percutaneous medial branch peripheral nerve stimulation (PNS) to determine if results from earlier, smaller single-center studies and reports were generalizable when performed at a larger number and wider variety of centers in patients recalcitrant to nonsurgical treatments. MATERIALS & METHODS Participants with chronic axial low back pain (LBP) were implanted with percutaneous PNS leads targeting the lumbar medial branch nerves for up to 60 days, after which the leads were removed. Participants were followed long-term for 12 months after the 2-month PNS treatment. Data collection is complete for visits through end of treatment with PNS (primary end point) and 6 months after lead removal (8 months after start of treatment), with some participant follow-up visits thereafter in progress. RESULTS Clinically and statistically significant reductions in pain intensity, disability, and pain interference were reported by a majority of participants. Seventy-three percent of participants were successes for the primary end point, reporting clinically significant (≥30%) reductions in back pain intensity after the 2-month percutaneous PNS treatment (n = 54/74). Whereas prospective follow-up is ongoing, among those who had already completed the long-term follow-up visits (n = 51), reductions in pain intensity, disability, and pain interference were sustained in a majority of participants through 14 months after the start of treatment. CONCLUSION Given the minimally invasive, nondestructive nature of percutaneous PNS and the significant benefits experienced by participants who were recalcitrant to nonsurgical treatments, percutaneous PNS may provide a promising first-line neurostimulation treatment option for patients with chronic axial back pain.
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- 2021
15. Use of Bone Marrow Concentrate to Treat Pain and Musculoskeletal Disorders: An Academic Delphi Investigation
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Christopher J, Centeno, Mairin A, Jerome, Sarah M, Pastoriza, Shane, Shapiro, Ken, Mautner, Gerard A, Malanga, Michael J, DePalma, R Amadeus, Mason, Ian, Stemper, and Ehren, Dodson
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Consensus ,Delphi Technique ,Bone Marrow ,Humans ,Pain ,Musculoskeletal Diseases ,United States - Abstract
Acute and degenerative musculoskeletal disorders are among the most common etiologies of disability worldwide. Recently, there has been interest in the field of regenerative medicine to bridge the gap between conservative and surgical management of these conditions. Autologous bone marrow concentrate is one type of injectate that has increased in popularity over the last few decades. Though there is promising evidence supporting its efficacy, standard of care practice guidelines to govern the appropriate use and implementation of such technology are currently lacking.The aim of this article is to report findings from a survey administered using the Delphi technique to a group of physicians using bone marrow concentrate in practice to determine best practice consensus regarding optimization of patient safety and education.Delphi panel technique.The study was first announced at a national meeting and continued remotely across the United States via 4 rounds of online surveys.An initial panel of 30 expert members was convened and a 5-member steering committee was established. Four rounds of consensus questionnaires totaling 11 unique questions were distributed. Ten questions included a 5-point Likert scale from "Strongly Agree" to "Strongly Disagree," and one question had a selection of 5 options regarding minimum level of evidence required. The anonymized aggregate results of each round were shared with the group prior to voting in the subsequent round in accordance with the Delphi process. Consensus was defined as 80% agreement of the statements indicating either "Strongly Agree" or "Agree" for the 10 questions with the Likert Scale and 80% agreement among 2 of 5 choices in the question regarding levels of evidence.Three invited participants were excluded by the second round of questions due to lack of response in a timely manner, leaving 27 physicians queried. Nine of the 11 questions met criteria for80% consensus. Areas of agreement included importance of a treatment registry, candidacy grading, expanded informed consent, scientific accuracy in advertising, institutional review board approval for novel uses, performance of procedures by only licensed physicians or mid-level providers with direct physician oversight, use of image guidance for injections, data submission for publication in peer reviewed literature, and a minimum requirement of case-series level of evidence for use of bone marrow concentrate in musculoskeletal medicine. The 2 areas that did not meet criteria for consensus included online publishing of individual clinic data and standards around cell counting for dosing.The Delphi panel of experts was convened on a voluntary basis rather than a nomination process. Our panel of experts were all physicians who use bone marrow concentrate in practice, therefore it is possible that a different panel of experts within other disciplines would reach different conclusions.There is significant consensus among a panel of physicians performing bone marrow concentrate injections regarding best practice guidelines for musculoskeletal conditions.
- Published
- 2021
16. Corrigendum to: Percutaneous PNS of the Medial Branch Nerves for the Treatment of Chronic Axial Back Pain in Patients following Radiofrequency Ablation
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Mehul J. Desai, Thomas J. Hopkins, Joseph W. Boggs, Abram H. Burgher, Timothy R. Deer, Meredith J McGee, Christopher A. Gilmore, Michael J. DePalma, David Spinner, Steven P. Cohen, and Sean Li
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Radiofrequency Ablation ,medicine.medical_specialty ,Percutaneous ,Radiofrequency ablation ,business.industry ,General Medicine ,Corrigenda ,law.invention ,Surgery ,Treatment Outcome ,Anesthesiology and Pain Medicine ,Text mining ,Back Pain ,law ,Transcutaneous Electric Nerve Stimulation ,Back pain ,medicine ,Humans ,In patient ,Peripheral Nerves ,Prospective Studies ,Neurology (clinical) ,medicine.symptom ,AcademicSubjects/MED00010 ,business - Abstract
Lumbar radiofrequency ablation is a commonly used intervention for chronic back pain. However, the pain typically returns, and though retreatment may be successful, the procedure involves destruction of the medial branch nerves, which denervates the multifidus. Repeated procedures typically have diminishing returns, which can lead to opioid use, surgery, or implantation of permanent neuromodulation systems. The objective of this report is to demonstrate the potential use of percutaneous peripheral nerve stimulation (PNS) as a minimally invasive, nondestructive, motor-sparing alternative to repeat radiofrequency ablation and more invasive surgical procedures.Prospective, multicenter trial.Individuals with a return of chronic axial pain after radiofrequency ablation underwent implantation of percutaneous PNS leads targeting the medial branch nerves. Stimulation was delivered for up to 60 days, after which the leads were removed. Participants were followed up to 5 months after the start of PNS. Outcomes included pain intensity, disability, and pain interference.Highly clinically significant (≥50%) reductions in average pain intensity were reported by a majority of participants (67%, n = 10/15) after 2 months with PNS, and a majority experienced clinically significant improvements in functional outcomes, as measured by disability (87%, n = 13/15) and pain interference (80%, n = 12/15). Five months after PNS, 93% (n = 14/15) reported clinically meaningful improvement in one or more outcome measures, and a majority experienced clinically meaningful improvements in all three outcomes (i.e., pain intensity, disability, and pain interference).Percutaneous PNS has the potential to shift the pain management paradigm by providing an effective, nondestructive, motor-sparing neuromodulation treatment.
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- 2021
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17. Common Neck Problems
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Michael J. DePalma, Shoji Ishigami, Justin J. Gasper, and Curtis W. Slipman
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medicine.medical_specialty ,Neck pain ,business.industry ,Psychological intervention ,Upper limb pain ,Diagnostic tools ,Cervical spine ,Neck problems ,Medicine ,Medical history ,Presentation (obstetrics) ,medicine.symptom ,business ,Intensive care medicine - Abstract
Successful treatment of painful cervical spine disorders hinges on the accurate assessment of the underlying tissue injury, which can involve a broad range of biomechanical and biochemical disorders. The clinician needs to conceptualize a process of diagnosis and treatment that incorporates an understanding of the pathophysiology of cervical spine injury and the associated potential symptom manifestations, an awareness of the advantages and disadvantages of the myriad of diagnostic tools, and knowledge of the potential therapeutic options. The initial step in this process is the history taking. It is important that one distinguish between cervical axial pain (neck pain) and upper limb pain. Evaluating and treating common cervical spine disorders requires the completion of a probability analysis of what injured structure is most likely responsible for the patient’s presentation. An astute spine clinician recognizes individual symptom composites to accurately diagnose and treat these injuries. This chapter is intended to be a foundation for approaching common painful cervical spine disorders, and provides a view of a tiered treatment algorithm, which incorporates appropriate therapeutic interventions across a spectrum of care.
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- 2021
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18. Contributors
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Denise M. Ambrosi, Michael Andary, Karen L. Andrews, Thiru M. Annaswamy, Dixie Aragaki, W. David Arnold, Arash Asher, James W. Atchison, Rita Ayyangar, Kim D.D. Barker, Touré Barksdale, Karen P. Barr, Matthew N. Bartels, Stacey A. Bennis, Theresa F. Berner, Cathy Bodine, Jaclyn Bonder, Angeline Bowman, Thomas N. Bryce, Mary Caldwell, William Carne, Priya Chandan, Shih-Ching Chen, Wen-Shiang Chen, Andrea Cheville, Li-Wei Chou, Jeffrey M. Cohen, Rory A. Cooper, Rosemarie Cooper, Anita Craig, Edan A. Critchfield, Deepthi S. Cull, Aaron Danison, Arthur J. De Luigi, Katherine Louise Dec, Andrew Cullen Dennison, Michael J. DePalma, Kelly M. Derby, Carmen P. DiGiovine, Timothy Dillingham, Carole Dodge, David F. Drake, Daniel Dumitru, Jason Edinger, Miguel X. Escalon, Reuben Escorpizo, James E. Eubanks, Gabriel Sunn Felsen, Jonathan Finnoff, Gerard E. Francisco, Kevin Franzese, Vincent Gabriel, Gary N. Galang, Justin J. Gasper, Lance L. Goetz, James W. Hall, R. Norman Harden, Mark A. Harrast, Julie A. Hastings, Radha Holavanahalli, Amy Houtrow, David Hryvniak, Lin-Fen Hsieh, Wei-Li Hsu, Vincent Huang, Elizabeth Huntoon, Sarah K. Hwang, Shoji Ishigami, Therese M. Jacobson, Carlos Anthony Jaramillo, Jeffrey Jenkins, Mariana M. Johnson, Stephen C. Johnson, Wade Johnson, Shawn Jorgensen, Brian M. Kelly, Lester J. Kiemele, Daniel J. Kim, Adam P. Klausner, Amy L. Kolarova, Alicia M. Koontz, Karen Kowalske, Christina Kwasnica, Dong Rak Kwon, Scott R. Laker, Erek W. Latzka, Melissa Lau, Yong-Tae Lee, Henry L. Lew, Sheng Li, Mark Linsenmeyer, William Lovegreen, Chuan-Chin Lu, Hui-Fen Mao, Craig M. McDonald, Christopher W. McMullen, Sudeep K. Mehta, Michelle A. Miller, Douglas P. Murphy, Ram N. Narayan, Christian M. Niedzwecki, John W. Norbury, Justin J.F. O’Rourke, Ajit B. Pai, Atul T. Patel, Terri K. Pogoda, Sofiya Prilik, David Z. Prince, Abu A. Qutubuddin, Mohammed I. Ranavaya, Zachary J. Resch, Gianna M. Rodriguez, Robert D. Rondinelli, Brendon Scott Ross, Adam Saby, Neelwant S. Sandhu, Mark Schmeler, Evan T. Schulze, Aloysia L. Schwabe, Kelly M. Scott, Young IL Seo, Anjali Shah, Terrence P. Sheehan, Lori V. Shuart, Beth A. Sievers, Andrew Simoncini, Mehrsheed Sinaki, Curtis W. Slipman, Sean Smith, Fantley Clay Smither, Jason R. Soble, Christopher J. Standaert, Steven P. Stanos, Siobhan M. Statuta, Phillip M. Stevens, Steven A. Stiens, Olaf Stüve, Chiemi Tanaka, Kate E. Temme, Sruthi P. Thomas, Ronald B. Tolchin, Mark D. Tyburski, Amy K. Wagner, Tyng-Guey Wang, Joseph B. Webster, Justin L. Weppner, Jonathan H. Whiteson, Robert P. Wilder, Lisa M. Williams, Laurie L. Wolf, Weibin Yang, Michael R. Yochelson, and Mauro Zappaterra
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- 2021
- Full Text
- View/download PDF
19. Regenerative Medicine : A Complete Guide for Musculoskeletal and Spine Disorders
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Corey W Hunter, Timothy T. Davis, Michael J. DePalma, Corey W Hunter, Timothy T. Davis, and Michael J. DePalma
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- Pain, Tissue engineering, Anesthesiology, Regenerative medicine, Pain--Treatment, Musculoskeletal system--Diseases--Treatment, Stem cells
- Abstract
This book explores the rapidly growing subspecialty of regenerative medicine in pain management. It provides concise guidelines and instruction for healthcare providers interested in implementing this novel therapy. The book contains three sections and begins with a thorough introduction to the field. Additionally, section one examines various therapies such as stem cell collection, allograft therapies, and bone marrow aspirations. Section two then delves into the medical diagnosis and procedural guidance methods, including ultrasound imaging, discography, local anesthetics, and anticoagulation medications. Following this, section three concludes the book with numerous discussions on standardized treatment paradigms. A unique, first-of-its-kind book, Regenerative Medicine seeks to inspire medical practitioners to integrate this subspecialty into pain management therapies and treatments.
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- 2023
20. 91. The viable disc tissue allograft supplementation (VAST) randomized controlled trial in patients with chronic discogenic low back pain: Correlating age with clinical outcome
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Richard D. Guyer, Michael J. DePalma, Mark I. Froimson, J. Kenneth Burkus, and Corey W. Hunter
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medicine.medical_specialty ,Visual analogue scale ,business.industry ,Placebo ,medicine.disease ,Low back pain ,law.invention ,Oswestry Disability Index ,Degenerative disc disease ,Surgery ,Randomized controlled trial ,law ,medicine ,Back pain ,Orthopedics and Sports Medicine ,Neurology (clinical) ,medicine.symptom ,business ,Lumbar disc disease - Abstract
BACKGROUND CONTEXT The development of chronic low back pain (LBP) results from internal disc disruption within the nucleus pulposus and is the most common etiology of LBP in young to middle-age adults. A viable disc tissue allograft has been developed to supplement tissue loss associated with degenerative lumbar disc disease and the development of chronic discogenic LBP. PURPOSE In this study, the clinical outcomes of patients in the VAST study were analyzed on the basis of patient age (above and below the median age of all patients). STUDY DESIGN/SETTING Randomized, controlled, multicenter study in US. PATIENT SAMPLE A total of 218 patients with chronic low back pain secondary to single-level or two-level degenerative disc disease were enrolled in the study. Patients had back pain for a minimum of 6 months that was recalcitrant to nonoperative treatment modalities. Inclusion criteria also included pretreatment VASPI ≥ 40 and ODI Score ≥ 40. OUTCOME MEASURES Oswestry Disability Index (ODI) and visual analog scale of pain intensity (VASPI), neurological exam and adverse events. Plain film radiographs and magnetic resonance (MR) imaging scans were used to assess disc space height and spinal alignment and to determine the degree of disc degeneration. METHODS Prospective, multicentered, blinded, randomized clinical trial for subjects with single or two-level degenerative lumbar disc disease was conducted. Patients had back pain for a minimum of 6 months, which was recalcitrant to nonoperative treatment modalities. Patients were blinded and randomized to receive intradiscal injections of either viable disc allograft or saline, or to continue nonblinded with nonsurgical management (NSM). The NSM group could cross over to the allograft group after 3 months. All patients crossed over into the investigational allograft treatment group. Patient data based on age comparing younger patients (19-42 years, 104 patients) to older patients (43-73 years, 114 patients) across all three groups were analyzed. Statistical analyses were performed based on 12-month post treatment improvements in ODI and VAS. RESULTS In the younger patient group, a significantly larger improvement in ODI of 29.7 points in the allograft treated group and 45.0 points in the cross over group was observed vs 17.4 points with the saline group (Overall p-value =.004). This effect was also observed in multiple responder analyses with a significantly higher percentage of allograft-treated patients demonstrating ≥15 and ≥20-point improvements in ODI vs the saline group. 69.1% of the younger patients treated with viable allograft vs 35.3% of the saline group showed clinically meaningful improvement of ODI ≥20-points (Overall p-value=.004). No significant interaction between treatment and age in VAS, and no significant benefits of allograft treatment on VAS in younger vs older patients was observed. Adverse events were reported in 30.9%, 10.5% and 17.6% of younger patients in the allograft, placebo, and conservative care groups, respectively (overall p value=0.155), compared to 28.8%, 15.8%, and 9.1% of older patients in these groups (overall p value=0.136), most commonly back pain. CONCLUSIONS This subgroup analysis indicates that younger patients (≤ 42 years) have more favorable clinical outcome vs older patients at 12 months. This data suggests that a viable disc tissue injection can effectively treat chronic discogenic LBP nonsurgically with meaningful results demonstrated in a younger patient population. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
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- 2021
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21. Cervical disc degeneration and neck pain
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Michael J DePalma and Baogan Peng
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medicine.medical_specialty ,discogenic neck pain ,Discography ,Degeneration (medical) ,cervical discography ,Asymptomatic ,03 medical and health sciences ,Myelopathy ,0302 clinical medicine ,medicine ,Cervical spondylosis ,030212 general & internal medicine ,Journal of Pain Research ,cervical intervertebral disc ,Cervical intervertebral disc ,Neck pain ,anterior cervical surgery ,business.industry ,Cervical discography ,medicine.disease ,Surgery ,Anesthesiology and Pain Medicine ,chronic neck pain ,disc degeneration ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Perspectives - Abstract
Baogan Peng,1 Michael J DePalma2 1Department of Spinal Surgery, General Hospital of Armed Police Force, Beijing 100039, People’s Republic of China; 2Interventional Spine and Musculoskeletal Care, Virginia iSpine Physicians, PC Virginia Spine Research Institute, Inc Richmond, VA, USA Abstract: Cervical intervertebral disc has long been considered a common source of neck pain. However, the pain caused by the disc itself has not been clearly defined so far, and its diagnosis and treatment has always been controversial. Degenerative cervical disc has a rich supply of nerve fibers, is prone to inflammatory reactions, and is susceptible to pain that can be provoked by disc stimulation or distention, and can be eliminated by block. Overwhelming clinical evidence demonstrates that neck pain in patients with degenerative cervical radiculopathy or myelopathy can be subsided rapidly by anterior cervical surgery, further indicating that this neck pain stems from the pathology of cervical disc itself. Cervical discography is advocated as the only test that connects disease to symptoms, but the procedure remains controversial. If strict criteria and technique are maintained, discography can discriminate painful, symptomatic discs from nonpainful, asymptomatic discs. Discogenic neck pain alone without cervical disc herniation or cervical spondylosis accounts for a large proportion of chronic neck pain. For these patients who continue to have refractory neck pain and fail to respond to conservative treatment, anterior cervical fusion surgery or artificial cervical disc replacement may be a better choice, and preoperative cervical discography can guarantee the excellent surgical results. Existing basic and clinical studies have scientifically shown that cervical intervertebral disc degeneration can lead to neck pain. Keywords: cervical intervertebral disc, chronic neck pain, discogenic neck pain, disc degeneration, anterior cervical surgery, cervical discography
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- 2018
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22. Intrathecal Pump Drug Delivery
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Douglas P. Beall, Peter L. Munk, Michael J. DePalma, Timothy Davis, Kasra Amirdelfan, Corey W. Hunter, Douglas P. Beall, Peter L. Munk, Michael J. DePalma, Timothy Davis, Kasra Amirdelfan, and Corey W. Hunter
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- Pain--Treatment, Injections, Spinal, Drug infusion pumps
- Abstract
This book is a comprehensive guide to Targeted Drug Delivery (TDD), also known as Intrathecal Drug Delivery (IDD), and offers an overview to this unique form of treatment. The medication is delivered by intrathecal pumps and is less common than some other techniques for interventional pain management, but is essential in conditions such as refractory pain, cancer pain, multifocal pain, severe spasticity, and in patients who are not candidates for surgical correction of their underlying condition. This book is the first source to describe both the optimal surgical implantation and patient management aspect of this therapy, and thus will be a valuable single reference guide for interventional radiologists, anesthesiologists, physiatrists, oncologists, neurologists, spine surgeons, palliative care physicians, and primary care physicians.
- Published
- 2022
23. 58. Viable disc tissue allograft supplementation in the treatment of degenerated intervertebral discs the one-year results of a randomized control trial
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Steven L Gershon, Gregory L. Wilson, Kasra Amirdelfan, Corey W. Hunter, Timothy T. Davis, Razmig Haladjian, Richard D. Guyer, William C. Tally, Michael J. DePalma, J. Kenneth Burkus, Meredith Langhorst, Randolph Bishop, and Douglas P. Beall
- Subjects
medicine.medical_specialty ,Visual analogue scale ,business.industry ,medicine.disease ,Low back pain ,Degenerative disc disease ,Oswestry Disability Index ,law.invention ,Surgery ,Lumbar ,Randomized controlled trial ,law ,Back pain ,medicine ,Orthopedics and Sports Medicine ,Neurology (clinical) ,medicine.symptom ,business ,Lumbar disc disease - Abstract
BACKGROUND CONTEXT A viable disc tissue allograft has been developed to supplement tissue loss associated with degenerative lumbar disc disease and the development of chronic discogenic lower back pain. The goal of an allogeneic disc matrix is to stabilize or restore the disc structure and normalize biomechanical functions and physiological loading to the disc. PURPOSE This unique viable disc allograft was injected into painful degenerated discs to evaluate safety and determine whether it can improve pain and function in patients with chronic discogenic low back pain. STUDY DESIGN/SETTING Randomized, controlled, multicenter study in US. PATIENT SAMPLE A total of 218 patients with chronic low back pain secondary to single-level or two-level degenerative disc disease were enrolled in the study. Patients had back pain for a minimum of 6 months that was recalcitrant to nonoperative treatment modalities. Inclusion criteria also included pretreatment VASPI ≥ 40 and ODI Score ≥ 40. OUTCOME MEASURES Clinical outcome instruments included Oswestry Disability Index (ODI) and visual analog scale of pain intensity (VASPI), neurological exam and adverse events. Plain film radiographs and magnetic resonance (MR) imaging scans were used to assess disc space height and spinal alignment, and to determine the degree of disc degeneration. METHODS Subjects were randomized and blinded to receive intradiscal injections of either viable disc allograft or saline or to continue nonblinded with nonsurgical management (NSM). The NSM group could cross over to the allograft group after 3 months. Patients were assessed at 6 and 12 months. Patient adverse events were continuously assessed. RESULTS At 12 months the VASPI and scores improved 30.5, 34.0, and 46.7 in the saline (S), active allograft (AA), and the crossover to allograft (COA) groups respectively, and the ODI scores improved 23.9, 27.4 and 36.4 in the same groups. This represents a 54% improvement in VASPI and a 53% improvement in ODI in the active allograft group. NSM subjects following crossover attained a 65% improvement in pain at 12 months combined with a 64% improvement in ODI. Responder rates were clinically significant for both ODI and VASPI with 76.5% of patients treated with AA showing improvement in ODI ≥ 15 points at 12 months vs 56.7% of patient treated in the S group (p=0.030) and 91.3% of the COA group vs 56.7% of the S group showing a ≥ 20-point improvement in VASPI (p=.006). In the allograft group, 11 safety adverse events occurred in 141 subjects (3.5%). The safety profile of the supplemental allograft was demonstrated to carry a risk similar to discography. CONCLUSIONS This large, prospective RCT showed safety and efficacy results demonstrating that viable disc tissue allograft is a safe treatment that produces significantly improved function and improved pain at 12 months. This technique may be a beneficial nonsurgical treatment for patients that have chronically painful lumbar degenerative discs. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
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- 2021
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24. Allogeneic mesenchymal precursor cells treatment for chronic low back pain associated with degenerative disc disease: a prospective randomized, placebo-controlled 36-month study of safety and efficacy
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Kee D. Kim, Gary Ghiselli, Randall Dryer, Timothy R. Deer, William Jeremy Beckworth, Roger D. Brown, Tory McJunkin, Hyun W. Bae, James Scott Bainbridge, Kasra Amirdelfan, and Michael J. DePalma
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Adult ,medicine.medical_specialty ,Visual analogue scale ,Population ,Context (language use) ,Intervertebral Disc Degeneration ,Placebo ,Degenerative disc disease ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,education ,Adverse effect ,030222 orthopedics ,education.field_of_study ,business.industry ,Australia ,Hematopoietic Stem Cell Transplantation ,medicine.disease ,Low back pain ,Oswestry Disability Index ,Treatment Outcome ,Surgery ,Neurology (clinical) ,medicine.symptom ,business ,Low Back Pain ,030217 neurology & neurosurgery - Abstract
BACKGROUND CONTEXT PURPOSE Evaluate the safety and efficacy of a single intradiscal injection of STRO-3+ adult allogeneic mesenchymal precursor cells (MPCs) combined with hyaluronic acid (HA) in subjects with chronic low back pain (CLBP) associated with degenerative disc disease (DDD) through 36-month follow-up. STUDY DESIGN/SETTING A multicenter, randomized, controlled study conducted at 13 clinical sites (12 in the United States and 1 in Australia). SUBJECT SAMPLE A total of 100 subjects with chronic low back pain associated with moderate DDD (modified Pfirrmann score of 3–6) at one level from L1 to S1 for at least 6 months and failing 3 months of conservative treatment, including physical therapy were randomized in a 3:3:2:2 ratio to receive 6 million MPCs with HA, 18 million MPCs with HA, HA vehicle control, or saline control (placebo) treatment. OUTCOME MEASURES Subjects were clinically and radiographically evaluated at 1, 3, 6, 12, 24, and 36 months postinjection. Subject-reported outcomes including adverse events, LBP on a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), SF-36 and Work Productivity and Activity Index were collected. METHODS Clinical and radiographic measures were collected at each visit. All randomized subjects were included in the safety assessments and analyzed based on the treatment received. Safety assessments included assessments of AEs, physical and radiographic examinations and laboratory testing. Efficacy assessments evaluated changes in VAS, ODI, and modified Pfirrmann (MP) scores between all active and control groups, respectively. Assessments included least squares mean (Mean), LS mean change from baseline (Mean Change) and responder analyses in order to assess the clinical significance of observed changes from baseline. The population for efficacy assessments was adjusted for the confounding effects of post-treatment interventions (PTIs). This study was conducted under an FDA Investigational New Drug application sponsored and funded by Mesoblast. RESULTS There were significant differences between the control and MPC groups for improvement in VAS and ODI. The PTI-corrected VAS and ODI Means and Mean Change analyses; the proportion of subjects with VAS ≥30% and ≥50% improvement from baseline; absolute VAS score ≤20; and ODI reduction ≥10 and ≥15 points from baseline showed MPC therapy superior to controls at various time points through 36 months. Additionally, the proportion of subjects achieving the minimally important change and clinically significant change composite endpoints for the MPC groups was also superior compared with controls at various time points from baseline to 36 months. There were no significant differences in change in MP score from baseline across the groups. There were also no statistically significant differences in change in modified MP score at the level above or below the level treated between study arms. Both the procedure and treatment were well tolerated and there were no clinical symptoms of immune reaction to allogeneic MPCs. There was a low rate of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events, and the rates of these events in the MPC groups were not significantly different from the control groups. One TEAE of severe back pain was possibly related to study agent and one TEAE of implantation site infection was considered to be related to the study procedure. CONCLUSIONS Results provide evidence that intradiscal injection of MPCs could be a safe, effective, durable, and minimally invasive therapy for subjects who have CLBP associated with moderate DDD.
- Published
- 2019
25. Chronic Spinal Pain: Pathophysiology, Diagnosis, and Treatment
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Michael J. DePalma, Baogan Peng, Nikolai Bogduk, and Ke Ma
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medicine.medical_specialty ,lcsh:R5-920 ,Article Subject ,business.industry ,MEDLINE ,Spinal pain ,Pathophysiology ,Editorial ,Anesthesiology and Pain Medicine ,Text mining ,Neurology ,Medicine ,business ,Intensive care medicine ,lcsh:Medicine (General) ,Introductory Journal Article - Published
- 2019
26. Twelve-month analgesia and rescue, by cooled radiofrequency ablation treatment of osteoarthritic knee pain: results from a prospective, multicenter, randomized, cross-over trial
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Michael J. DePalma, Eric Loudermilk, Marc Soloman, Corey W. Hunter, Anita Gupta, Mehul J. Desai, Elizabeth Cook, Nileshkumar Patel, David Lindley, Leonardo Kapural, Tim R.C. Davis, and Daniel Choi
- Subjects
medicine.medical_specialty ,Radiofrequency ablation ,business.industry ,Chronic pain ,General Medicine ,Osteoarthritis ,medicine.disease ,Crossover study ,Surgery ,law.invention ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,Anesthesiology and Pain Medicine ,Knee pain ,030202 anesthesiology ,law ,medicine ,Osteoarthritic knee ,Interventional pain management ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
Background and objectivesAs a follow-up to the 6-month report,12 this study investigated the analgesic effect of cooled radiofrequency ablation (CRFA) in patients with knee osteoarthritis (OA) 12 months postintervention and its ability to provide pain relief in patients who experienced unsatisfactory effects of intra-articular steroid injection (IAS).MethodsSeventy-eight per cent (52/67) of patients originally treated with CRFA were evaluated at 12 months, while at 6 months post-IAS, 82% (58/71) of those patients crossed over to CRFA and assessed 6 months later.ResultsAt 12 months, 65% of the original CRFA group had pain reduction ≥50%, and the mean overall drop was 4.3 points (pConclusionsThis study demonstrates that analgesia following CRFA for OA knee pain could last for at least 12 months and could rescue patients who continue to experience intolerable discomfort following IAS.Clinical trial registrationThe ClinicalTrials.gov registration number for this study isNCT02343003.
- Published
- 2018
27. Lumbar Disc Disorders
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Daniel L. Kline and Michael J. DePalma
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Lumbar disc ,business.industry ,Medicine ,Anatomy ,business - Abstract
This chapter focuses on the diagnosis and treatment of discogenic low back pain. Discogenic low back pain is a prevalent condition that affects a large percentage of the adult population. Diagnosis and treatment of this condition remain challenging despite ongoing advances. Provocation lumbar discography has allowed for more accurate identification of painful discs than conventional imaging techniques. Current research focusing on regenerative treatment options may hold promise for the future.
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- 2018
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28. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study
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Philip Yuan, David Greg Anderson, S. Kitchel, Joerg Franke, Christopher A. Yeung, L. Thibodeau, Rick C. Sasso, Eeric Truumees, Hyun W. Bae, M. Schaufele, Michael J. DePalma, Alfred L. Rhyne, Bernhard Meyer, Peter Vajkoczy, and Jeffrey S. Fischgrund
- Subjects
Radiofrequency ablation ,medicine.medical_treatment ,Population ,Investigational device exemption ,law.invention ,Degenerative disc disease ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine ,Clinical endpoint ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,education ,education.field_of_study ,business.industry ,Modic changes ,Ablation ,medicine.disease ,humanities ,ddc ,Anesthesia ,Surgery ,business ,030217 neurology & neurosurgery - Abstract
To evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP. A total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25–69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months. At 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months. Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain. These slides can be retrieved under Electronic Supplementary Material.
- Published
- 2018
29. Intradiscal Biologic Treatments: Allogeneic Stem Cells
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Michael J. DePalma and Daniel L. Kline
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medicine.medical_specialty ,business.industry ,Intervertebral disc ,Internal disc disruption ,Low back pain ,Surgery ,Chronic low back pain ,medicine.anatomical_structure ,Back pain ,medicine ,medicine.symptom ,Stem cell ,business ,human activities ,health care economics and organizations - Abstract
Low back pain has been estimated to affect 15–20% of adults in any given year, and 80% over the course of their lifetime [1]. Furthermore, it has been estimated that at some point, 28% of adults will experience disabling low back pain [2]. A 2011 study found that the intervertebral disc accounted for 42% of the cases of chronic low back pain [3]. Prior studies support this finding and have estimated a similar rate of 39% for internal disc disruption (IDD) [4]. These statistics are especially troubling because of the lack of a reliable means of treating discogenic low back pain.
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- 2018
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30. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy
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Shay Bess, Anthony J. Lisi, Jonathan N. Sembrano, Anil K. Sharma, Jeffrey T. Summers, Christopher K. Taleghani, Charles H. Cho, William L Tontz, Michael J. DePalma, Steven W. Hwang, Tim J. Lamer, Robert C. Nucci, Gary Ghiselli, Daniel K. Resnick, D. Scott Kreiner, Paul Dougherty, Jamie L. Baisden, Daniel J. Mazanec, Rakesh D. Patel, Amgad S. Hanna, John F. Toton, John E. Easa, Richard J. Meagher, and Robert Fernand
- Subjects
medicine.medical_specialty ,Evidence-Based Medicine ,Evidence-based practice ,business.industry ,MEDLINE ,Injections, Epidural ,Subject (documents) ,Context (language use) ,Recovery of Function ,Evidence-based medicine ,Guideline ,Treatment Outcome ,Nominal group technique ,Physical therapy ,Humans ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Lumbar disc herniation ,Radiculopathy ,business ,Glucocorticoids ,Intervertebral Disc Displacement ,Diskectomy - Abstract
Background context The objective of the North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy is to provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of lumbar disc herniation with radiculopathy. The guideline is intended to reflect contemporary treatment concepts for symptomatic lumbar disc herniation with radiculopathy as reflected in the highest quality clinical literature available on this subject as of July 2011. The goals of the guideline recommendations are to assist in delivering optimum efficacious treatment and functional recovery from this spinal disorder. Purpose To provide an evidence-based educational tool to assist spine specialists in the diagnosis and treatment of lumbar disc herniation with radiculopathy. Study design Systematic review and evidence-based clinical guideline. Methods This guideline is a product of the Lumbar Disc Herniation with Radiculopathy Work Group of NASS' Evidence-Based Guideline Development Committee. The work group consisted of multidisciplinary spine care specialists trained in the principles of evidence-based analysis. A literature search addressing each question and using a specific search protocol was performed on English-language references found in Medline, Embase (Drugs and Pharmacology), and four additional evidence-based databases to identify articles. The relevant literature was then independently rated using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final recommendations to answer each clinical question were developed via work group discussion, and grades were assigned to the recommendations using standardized grades of recommendation. In the absence of Level I to IV evidence, work group consensus statements have been developed using a modified nominal group technique, and these statements are clearly identified as such in the guideline. Results Twenty-nine clinical questions were formulated and addressed, and the answers are summarized in this article. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. Conclusions The clinical guideline has been created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with symptomatic lumbar disc herniation with radiculopathy. The entire guideline document, including the evidentiary tables, suggestions for future research, and all the references, is available electronically on the NASS Web site at http://www.spine.org/Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx and will remain updated on a timely schedule.
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- 2014
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31. Comparison of Four Different Analgesic Discogram Protocols Comparing the Incidence of Reported Pain Relief Following Local Anesthetic Injection into Concordantly Painful Lumbar Intervertebral Discs
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Jeong Eun Lee, Michael J. DePalma, Richard Derby, Ray M. Baker, and Charles Aprill
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Adult ,Male ,medicine.medical_specialty ,medicine.drug_class ,Analgesic ,Provocation test ,Contrast Media ,Discography ,Sensitivity and Specificity ,Cohort Studies ,Lumbar ,Humans ,Medicine ,Prospective Studies ,Anesthetics, Local ,Intervertebral Disc ,Injections, Spinal ,Pain Measurement ,business.industry ,Local anesthetic ,Incidence (epidemiology) ,General Medicine ,Middle Aged ,Surgery ,Catheter ,Anesthesiology and Pain Medicine ,Anesthesia ,Neuroradiography ,Tears ,Female ,Neurology (clinical) ,business ,Low Back Pain - Abstract
Objective To compare the incidence of pain relief following injection of local anesthetic (LA) into lumbar discs that caused concordant pain during provocation testing. Design Prospective collected data review from two centers and compare with published results. Outcome Measures We compared subjective reported pain relief following provocative testing using the following protocols at three separate facilities: 23 patients undergoing routine provocative discography using contrast alone (PD); 47 patients undergoing provocative discography performed using an equal combination of LA and contrast (CPD); 120 patients injected with LA following routine PD (ADPD); 33 patients undergoing stand-alone analgesic discography (SAAD); and 28 patients injected with LA through a catheter (FAD) placed during provocative discogaphy testing. Results Pressure-controlled PD showed a positive response rate of 34% per disc in patients with a clinical diagnosis of discogenic pain. None of the PD group without LA had pain relief and less than 10% of the CPD group reported pain relief. Forty percent of the SAAD group with positive pain reproduction reported ≥50% relief and 20% reporting ≥80% relief. Forty-six percent of the ADPD group reported ≥50% relief and 30% reporting ≥80% relief. The FAD group had a greater 80% patients reporting ≥50% pain relief although fewer 26% reporting more convincing ≥80% relief. Conclusions If the criterion standard to confirm painful annular tears is concordant pain provocation and 80% or greater pain relief following LA injected into lumbar discs, the SAAD, ADPD, and FAD protocols show statistically similar 20% to 30% prevelance.
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- 2012
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32. Multivariable Analyses of the Relationships Between Age, Gender, and Body Mass Index and the Source of Chronic Low Back Pain
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Jessica M. Ketchum, Michael J. DePalma, and Thomas R. Saullo
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Sacroiliac joint ,medicine.medical_specialty ,business.industry ,Chronic pain ,Retrospective cohort study ,General Medicine ,medicine.disease ,Comorbidity ,Low back pain ,Facet joint ,Anesthesiology and Pain Medicine ,Lumbar ,medicine.anatomical_structure ,Physical therapy ,Medicine ,Neurology (clinical) ,medicine.symptom ,business ,Body mass index - Abstract
Objective. To examine the combined relationships between age, gender, and body mass index (BMI) and the specific source of chronic low back pain. Design. Retrospective chart review. Setting. University spine center. Patients. Charts from 378 cases from 358 consecutive patients were reviewed and 157 independent cases from 153 patients who underwent definitive diagnostic injections were analyzed. Interventions. Discography, dual diagnostic facet joint blocks, sacroiliac joint injections, anesthetic interspinous ligaments/opposing spinous processes/posterior fusion hardware injections, percutaneous augmentation. Outcome Measures. Chronic low back pain source was the primary outcome variable. Predictor variables included age at initial presentation, gender, and BMI. Results. Age, gender, and BMI were each significantly associated with the source of chronic low back pain, after controlling for the effects of each other. Increases in age were associated with significant decreases in the odds of internal disc disruption (IDD) vs facet joint pain (FJP), sacroiliac joint pain (SIJP), and other sources and decreases in the odds of FJP and SIJP vs other sources. Being female was associated with significant increases in the odds of SIJP vs IDD, FJP, and other sources. Increased BMI was associated with significant increases in the odds of FJP vs SIJP. Conclusions. These findings suggest a significant relationship among gender, age, and BMI and structural causes of chronic low back pain. Lumbar IDD is more prevalent in young males while FJP is more prevalent in females with increased BMI. Female gender and low BMI are associated with SIJP.
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- 2012
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33. Multivariable Analysis of the Relationship Between Pain Referral Patterns and the Source of Chronic Low Back Pain
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Ben L. Laplante, Jessica M. Ketchum, Michael J. DePalma, and Thomas R. Saullo
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musculoskeletal diseases ,Sacroiliac joint ,medicine.medical_specialty ,Referral ,business.industry ,Provocation test ,Retrospective cohort study ,Low back pain ,Facet joint ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Etiology ,Physical therapy ,Medicine ,Girdle pain ,medicine.symptom ,business - Abstract
Background: Discogenic, facet joint, and sacroiliac joint mediated axial low back pain may be associated with overlapping pain referral patterns into the lower limb. Differences between pain referral patterns for these three structures have not been systematically investigated. Objective: To examine the individual and combined relationship of age, hip/girdle pain, leg pain, and thigh pain and the source of internal disc disruption (IDD), facet joint pain (FJP), or sacroiliac joint pain (SIJP) in consecutive chronic low back pain (CLBP) patients. Design: Retrospective chart review. Setting: Community based interventional spine practice. Patients: 378 cases from 358 consecutive patients were reviewed and 157 independent cases from 153 patients who underwent definitive diagnostic injections were analyzed. Methods: Charts of consecutive low back pain patients who underwent definitive diagnostic spinal procedures were retrospectively reviewed. Patients underwent provocation lumbar discography, dual diagnostic medial branch blocks, or intra-articular diagnostic sacroiliac joint injections based on clinical presentation. Some subjects underwent multiple diagnostic injections until the source of their chronic low back pain (CLBP) was identified. Main Outcome Measurements: Based on the results of diagnostic injections, subjects were classified as having IDD, FJP, SIJP, or other. The mean age/standard deviation and the count/percentage of patients reporting hip girdle pain, leg pain, or thigh pain were estimated for each diagnostic group and compared statistically among the IDD, FJP, SIJP, and other source groups. Next, the 4 predictor variables were simultaneously modeled with a single multinomial logistic regression model to explore the adjusted relationship between the predictors and the source of CLBP. Results: The mean age was significantly different among the source groups. IDD cases were significantly younger than FJP, SIJP, and other source groups and FJP cases were significantly younger than other sources. The age by thigh pain interaction effect was statistically significant (P = 0.021), indicating that the effect of age on the source of CLBP depends on thigh pain, and similarly, that the effect of thigh pain on the source of CLBP depends on age. Limitations: Retrospective study design. Conclusions: The presence or absence of thigh pain possesses a significant correlation on the source of CLBP for varying ages, whereas the presence of hip/girdle pain or leg pain did not significantly discriminate among IDD, FJP, or SIJP as the etiology of CLBP. Younger age was predictive of IDD regardless of the presence or absence of thigh pain. Key words: low back pain, intervertebral disc, zygapophyseal joint, sacroiliac joint, pain referral patterns
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- 2012
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34. Is the History of a Surgical Discectomy Related to the Source of Chronic Low Back Pain?
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Thomas R. Saullo, Michael J. DePalma, Ben L. Laplante, and Jessica M. Ketchum
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musculoskeletal diseases ,Sacroiliac joint ,medicine.medical_specialty ,Discogenic pain ,business.industry ,medicine.medical_treatment ,Provocation test ,Retrospective cohort study ,Low back pain ,Surgery ,Facet joint ,Exact test ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Discectomy ,medicine ,Physical therapy ,medicine.symptom ,business - Abstract
Background: Recurrent or persistent low back pain (LBP) after surgical discectomy (SD) for intervertebral disc herniation has been well documented. The source of low back pain in these patients has not been examined. Objective: To compare the distribution of the source of chronic LBP between patients with and without a history of SD. Study Design: Retrospective chart review. Setting: Academic spine center. Patients: Charts from 358 consecutive patients were reviewed. Charts noting the absence/ presence of SD in patients who subsequently underwent diagnostic injections to determine the source of chronic LBP were included resulting in 158 unique cases for analysis. Methods: Patients underwent either dual diagnostic facet joint blocks, intra-articular diagnostic sacroiliac joint injections, provocation lumbar discography, or anesthetic injection into putatively painful interspinous ligaments/opposing spinous processes/posterior fusion hardware. If the initial diagnostic procedure was negative, the next most likely structure in the diagnostic algorithm was interrogated. Subsequent diagnostic procedures were not performed after the source of chronic LBP was identified. Outcome: The source of chronic LBP was diagnosed as discogenic pain (DP), facet joint pain (FJP), sacroiliac joint pain (SIJP), or other sources of chronic LBP. Results: Based on a Fisher’s exact test, there was marginal evidence the distribution of the source of chronic LBP differed for those with and without a history of SD (P = 0.080). Posthoc comparisons suggested that patients with a history of SD have a higher probability of DP compared to those without a history of SD (82% versus 41%; P = 0.011). Differences in the probability of FJP, SIJP, or other sources between the SD history groups were not significant. Limitations: Small sample size, restrospective design, and possible false-positive results. Conclusions: This is the first published investigation of the tissue source of chronic LBP after SD. It appears that DP is the most common reason for chronic LBP after SD. If more rigorous study confirms our findings, future biologic treatments may hold value in repairing symptomatic annular fissures after SD. Key words: surgical discectomy, chornic low back pain, discogenic pain, facet joint, sacroiliac joint, low back pain, diagnostic injections, medial branch block, lumbar provcation discography
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- 2012
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35. Treatment of Chronic Low Back Pain via Ablation of the Basivertebral Nerve: Results of the Smart Trial
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Peter Vajkoczy, Rick C. Sasso, Jeffrey S. Fischgrund, Joerg Franke, Alfred L. Rhyne, Hyun W. Bae, and Michael J. DePalma
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Physical therapy ,Medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,Ablation ,Chronic low back pain - Published
- 2017
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36. Structural Etiology of Chronic Low Back Pain Due to Motor Vehicle Collision
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Jessica M. Ketchum, Thomas Saullo, Michael J. DePalma, and Jerome Schofferman
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Adult ,Male ,musculoskeletal diseases ,medicine.medical_specialty ,Facet (geometry) ,Poison control ,Discography ,Facet joint ,Lumbar ,medicine ,Humans ,Injections, Spinal ,Retrospective Studies ,Sacroiliac joint ,business.industry ,Accidents, Traffic ,Chronic pain ,General Medicine ,Middle Aged ,musculoskeletal system ,medicine.disease ,Low back pain ,Spine ,Surgery ,Treatment Outcome ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Physical therapy ,Female ,Neurology (clinical) ,Chronic Pain ,medicine.symptom ,business ,Low Back Pain - Abstract
Objective. To estimate prevalence rates of discogenic, facet, and sacroiliac joint pain, and describe clinical features of chronic low back pain patients whose symptoms were initiated by motor vehicle collisions. Design. Retrospective chart review. Setting. Academic spine center. Patients. Twenty-seven motor vehicle collision-induced chronic low back pain patients were included after undergoing diagnostic procedures. Interventions. Lumbar provocation discography, dual diagnostic facet joint blocks, and intra-articular sacroiliac joint injections. Methods. Enrolled patients underwent diagnostic procedures based on clinical presentation until the pain source was identified. The prevalence of each source of low back pain was estimated. Clinical, categorical, and continuous characteristics within the source groups were calculated with SAS v.9.2 (SAS Institute Inc., Cary, NC). Outcome Measures. Etiology and prevalence were analyzed for each diagnosis group. Results. Of the 27 patients, 15/27 (56%) were diagnosed with discogenic pain, 7/27 (26%) with sacroiliac joint pain, and 5/27 (19%) with facet joint pain. Seventy-eight percent were female. Mean age was 42.5 years (standard deviation = 10.4) with median duration of symptoms of 24 months (interquartile range = 6-48). Conclusions. Our study is the first to demonstrate that diagnostic spinal injections can identify particular spinal structures, namely the intervertebral disc, facet joint, and sacroiliac joint, as the specific source of chronic low back pain due to inciting motor vehicle collisions. The most common source of motor vehicle collision-induced chronic low back pain appears to be the disc followed by the sacroiliac and facet joints. Language: en
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- 2011
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37. Etiology of Chronic Low Back Pain in Patients Having Undergone Lumbar Fusion
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Michael J. DePalma, Thomas Saullo, and Jessica M. Ketchum
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Adult ,musculoskeletal diseases ,medicine.medical_specialty ,medicine.medical_treatment ,Zygapophyseal Joint ,Facet joint ,Lumbar ,medicine ,Humans ,Intervertebral Disc ,Aged ,Retrospective Studies ,Sacroiliac joint ,Lumbar Vertebrae ,Referred pain ,business.industry ,Chronic pain ,Sacroiliac Joint ,General Medicine ,Middle Aged ,medicine.disease ,Low back pain ,Surgery ,Spinal Fusion ,Treatment Outcome ,Anesthesiology and Pain Medicine ,medicine.anatomical_structure ,Joint pain ,Spinal fusion ,Chronic Disease ,Female ,Neurology (clinical) ,Joint Diseases ,medicine.symptom ,business ,Low Back Pain ,Intervertebral Disc Displacement - Abstract
Objective. To estimate the prevalence of lumbar internal disc disruption, zygapohyseal joint pain, sacroiliac joint pain, and soft tissue irritation by fusion hardware in post-fusion low back pain patients compared with non-fused patients utilizing diagnostic spinal procedures. Design. Retrospective chart review. Setting. University spine center. Patient Sample. Patients presenting to a community-based, multidisciplinary, academic spine center (65.9% female, mean age 54.4 years, median pain duration 12 months). Interventions. Charts of consecutive low back pain cases completing diagnostic spinal procedures including provocation discography and zygapohyseal joint, sacroiliac joint, and fusion hardware blockade were retrospectively reviewed. Outcome Measures. Based on the results of discography and/or diagnostic blockades, subjects were classified with internal disc disruption, zygapohyseal joint pain, sacroiliac joint pain, or fusion hardware related pain. Results. The diagnoses of 28 fusion cases identified from 170 low back pain patients undergoing diagnostic procedures included 12 with sacroiliac joint pain, seven with internal disc disruption, five with zygapohyseal joint pain, and four due to soft tissue irritation from fusion hardware. No significant differences were noted in zygapohyseal joint mediated pain with and without fusion history. Mean ages of patients were similar with and without fusion history for cases diagnosed as internal disc disruption. Conclusion. In patients' recalcitrant to non-interventional care, the sacroiliac joint is the most likely source of low back pain after lumbar fusion followed by internal disc disruption, zygapohyseal joint pain, and soft tissue irritation due to fusion hardware. Sacroiliac joint pain is more common after fusion, while internal disc disruption is more common in non-fusion patients.
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- 2011
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38. Does the Location of Low Back Pain Predict Its Source?
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Curtis W. Slipman, Thomas R. Saullo, Michael J. Depalma, Brian S. Trussell, and Jessica M. Ketchum
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Adult ,musculoskeletal diseases ,medicine.medical_specialty ,Provocation test ,Physical Therapy, Sports Therapy and Rehabilitation ,Sensitivity and Specificity ,Zygapophyseal Joint ,Facet joint ,Lumbar ,Interquartile range ,Positive predicative value ,Internal medicine ,medicine ,Humans ,Aged ,Retrospective Studies ,Sacroiliac joint ,business.industry ,Rehabilitation ,Retrospective cohort study ,Middle Aged ,Low back pain ,Surgery ,medicine.anatomical_structure ,Neurology ,Neurology (clinical) ,medicine.symptom ,business ,Low Back Pain ,Autonomic Nerve Block - Abstract
To evaluate the predictive utility of the pattern of low back pain (LBP) in detecting the source of LBP as internal disk disruption (IDD), facet joint pain (FJP), or sacroiliac joint pain (SIJP).Retrospective chart review.University spine center.A total of 170 cases from 156 patients presenting with LBP whose low back disorder was definitively diagnosed. The mean age was 54.4 years (SD, 16.2) and median duration of LBP was 12 months (interquartile ranges, 6-32).Charts of consecutive LBP patients who underwent definitive diagnostic spinal procedures including provocation diskography, facet joint blocks, and sacroiliac joint blocks were retrospectively reviewed. Each patient with LBP was queried as to the exact location of their LBP: midline, defined as in-line with the spinous processes, and/or paramidline, defined as lateral to 1 fingerbreadth adjacent to the midline.In patients with a definitive diagnosis for the source of LBP, the proportion of each diagnosed source of pain was calculated. χ(2) tests were used to identify differences in the percentages of midline and paramidline LBP among the groups of patients testing positive for IDD, FJP, or SIJP. Diagnostic measures of sensitivity, specificity, positive and negative predictive values, diagnostic accuracy, and likelihood ratios of positive and negative tests using the presence/absence of midline and paramidline pain for the diagnosis of IDD, FJP, and SIJP were estimated.With cases of IDD, significantly greater percentages of patients reported midline LBP (95.8%; χ(2) = 101.4, df = 2, P.0001) as compared with cases of FJP (15.4%) or SIJP (12.9%). In cases of IDD, significantly lower percentages of patients reported paramidline pain (67.3%; χ(2) = 16.1, df = 2, P = .0003) as compared with cases of FJP (95.0%) or SIJ (96.0%). In cases of IDD, significantly greater percentages of patients reported midline LBP (95.8%; χ(2) = 101.4, df = 2, P.0001) as compared with cases of FJP (15.4%) or SIJP (12.9%). The specificity of midline LBP for IDD, FJP, and SIJP was 74.8% (95% CI = 65.0%-82.9%), 28.0% (20.1%-37.0%), and 36.0% (28.0%-44.5%), respectively. The negative predictive value of paramidline LBP for IDD, FJP, and SIJP was 29.2% (95% CI = 12.6%-51.1%), 91.7% (73.0%-99.0%), and 95.8% (78.9%-99.9%). The diagnostic accuracy of midline LBP for IDD, FJP, and SIJP was 83.5%, 24.1%, and 31.8%, respectively.The presence of midline LBP increases the probability of lumbar IDD and reduces the probability of symptomatic FJ and SIJ dysfunction. The presence of isolated paramidline LBP increases the probability of symptomatic FJ or SIJ but mildly reduces the likelihood of lumbar IDD.
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- 2011
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39. Detecting and Treating Shoulder Impingement Syndrome
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Ernest W. Johnson and Michael J. DePalma
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musculoskeletal diseases ,medicine.medical_specialty ,Rehabilitation ,business.industry ,medicine.medical_treatment ,Physical Therapy, Sports Therapy and Rehabilitation ,musculoskeletal system ,medicine.anatomical_structure ,Scapula ,Subacromial impingement ,Muscle dysfunction ,medicine ,Shoulder Impingement Syndrome ,Physical therapy ,Orthopedics and Sports Medicine ,Shoulder joint ,Rotator cuff ,business ,Range of motion - Abstract
The shoulder joint is most appropriately referred to as the "shoulder complex," since its total range of motion depends on four interworking articulations. The scapula is central in proficient shoulder activity, and rotator cuff muscles will not operate optimally if the scapula is poorly positioned. Dynamic scapular stabilization requires coordinated muscular activity, and muscle dysfunction will lead to glenohumeral incongruity during overhead athletic activities. Lack of scapular protraction, upward rotation, and posterior tilting can lead to subacromial impingement. Pain inhibition and fatigue can also provoke altered muscle patterns, but rehabilitation exercises can address biomechanic deficiencies.
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- 2010
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40. Efficacy and Safety of Percutaneous Sacroplasty for Painful Osteoporotic Sacral Insufficiency Fractures
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Jonathan Daitch, David X. Cifu, Michael J. DePalma, Michael E. Frey, and Sarjoo M. Bhagia
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Male ,Sacrum ,medicine.medical_specialty ,Percutaneous ,Visual analogue scale ,Sedation ,Neurosurgical Procedures ,Cohort Studies ,Weight-Bearing ,Postoperative Complications ,Polymethacrylic Acids ,Multicenter trial ,medicine ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Radiculopathy ,Prospective cohort study ,Aged ,Pain Measurement ,Sacroiliac joint ,business.industry ,Bone Cements ,Magnetic Resonance Imaging ,Low back pain ,Surgery ,Treatment Outcome ,medicine.anatomical_structure ,Anesthesia ,Osteoporosis ,Spinal Fractures ,Female ,Neurology (clinical) ,medicine.symptom ,Spinal Nerve Roots ,business ,Low Back Pain - Abstract
Study design A prospective observational cohort study of consecutive osteoporotic patients with sacral insufficiency fractures (SIFs). Objective Assess the safety and efficacy of sacroplasty in treating osteoporotic SIFs. Summary of background data SIFs can cause low back pain in osteoporotic patients. Symptomatic improvement may require up to 12 months. Treatment includes limited weight-bearing and bed rest, oral analgesics, and sacral corsets. Significant mortality and morbidity are associated with pelvic insufficiency fractures. Percutaneous sacroplasty is an alternative treatment for SIF patients, and initial reports have documented its safe and effective performance. Yet, follow-up intervals have been short, and study cohorts small precluding definitive assessment of sacroplasty's safety and efficacy. Methods Baseline Visual Analogue Scale (VAS), analgesic usage, and duration of symptoms were recorded. Subsequent VAS ratings were assessed at 30 minutes and at 2, 4, 12, 24, and 52 weeks postprocedure. Analgesic usage and patient satisfaction were assessed at final follow-up. Each procedure was performed under intravenous conscious sedation using fluoroscopy. Two bone trochars were inserted between the sacral foramen and sacroiliac joint through which 2 to 3 mL of polymethylmethacrylate was injected. Results Thirty-seven patients, 27 females, were treated. Mean age was 76.6 years, and mean symptom duration was 34.4 days. All patients were available at each follow-up interval except 1 patient who died due to unrelated pulmonary disease before the 4-week follow-up. The mean VAS score at baseline was 7.7 and 3.2 within 30 minutes, and 2.1 at 2, 1.7 at 4, 1.3 at 12, 1.0 at 24, and 0.7 at 52 weeks postprocedure. Improvement at each interval and overall was statistically significant using the Wilcoxon Rank Sum Test. One case of transient S1 radiculitis was encountered. Conclusions Sacroplasty appears to be a safe and effective treatment for painful SIF. The rate of improvement is rapid and sustained through 1 year.
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- 2007
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41. Physical therapy for low back pain
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Daniel E. Gelb, Michael J. DePalma, Steven C. Ludwig, and Amit Bhargava
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medicine.medical_specialty ,business.industry ,Physical therapy ,Medicine ,Surgery ,medicine.symptom ,business ,Low back pain ,Low back ,Medical literature - Abstract
Purpose of reviewThe aim of this article is to critically review the recently available trials investigating physical therapy for low back pain.Recent findingsA medical literature search was conducted for articles published in 2005 that incorporated the key words of physical therapy, low back pain
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- 2006
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42. A Critical Appraisal of the Evidence for Selective Nerve Root Injection in the Treatment of Lumbosacral Radiculopathy
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Curtis W. Slipman, Amit Bhargava, and Michael J. DePalma
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Clinical Trials as Topic ,medicine.medical_specialty ,Randomization ,Nerve root ,business.industry ,medicine.medical_treatment ,Lumbosacral Plexus ,Rehabilitation ,MEDLINE ,Nerve Block ,Physical Therapy, Sports Therapy and Rehabilitation ,Surgery ,Clinical trial ,Critical appraisal ,Lumbar ,Anesthesia ,medicine ,Nerve block ,Humans ,Radiculopathy ,business ,Glucocorticoids ,Injections, Spinal ,Lumbosacral joint - Abstract
DePalma MJ, Bhargava A, Slipman CW. A critical appraisal of the evidence for selective nerve root injection in the treatment of lumbosacral radiculopathy. Objective To critically review the best available trials of the utility of transforaminal epidural steroid injections (TFESIs) or selective nerve root blocks (SNRBs) to treat lumbosacral radiculopathy. Data Sources MEDLINE (PubMed, Ovid, MDConsult), EMBASE, and the Cochrane database. Databases were searched from inception through 2003. Study Selection A database search was conducted by using the following key words: prospective , transforaminal and foraminal epidural steroid injections , selective nerve root block and injection , and periradicular and nerve root injection . We included English-language, prospective, randomized studies of patients with lower-limb radicular symptoms treated with fluoroscopically guided nerve root or transforaminal epidural injections. Data Extraction Data were compiled for each of the following categories: inclusion criteria, randomization protocol, total number of subjects enrolled initially and at final analysis, statistical analysis utilized, documentation of technique, outcome measures, follow-up intervals and results (positive or negative), and reported complications. These data were abstracted by 1 reviewer and reviewed by a second. Study quality was assessed with the system developed by the Agency for Health Care and Policy Research. Data Synthesis We selected 6 articles for review. Our analysis identified a single article as the highest quality study addressing the appropriate use of TFESIs or therapeutic SNRBs. Coupled with the evidence provided by 4 other articles (1 article was excluded because its patients were not truly randomized), our review of the evidence for TFESIs found level III (moderate) evidence in support of these minimally invasive and safe procedures in treating painful radicular symptoms. However, conclusive evidence (level I) is lacking. Conclusions The evidence for TFESIs reveals level III (moderate) evidence in support of these minimally invasive and safe procedures in treating painful lumbar radicular symptoms. Current studies support use of TFESIs as a safe and minimally invasive adjunct treatment for lumbar radicular symptoms. However, more prospective, randomized, placebo-controlled studies using sham procedures are needed to provide conclusive evidence for the efficacy of TFESIs in treating lumbar radicular symptoms.
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- 2005
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43. Injection therapy for lumbar radiculopathy
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Steven C. Ludwig, Curtis W. Slipman, Amit Bhargava, Michael J. DePalma, and Daniel E. Gelb
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medicine.medical_specialty ,Epidural steroid ,Lumbar radiculopathy ,business.industry ,MEDLINE ,Injection therapy ,medicine ,Surgery ,business ,Lumbosacral joint ,Medical literature - Abstract
Purpose of reviewTo review critically the available trials investigating the utility of epidural steroid injections to treat lumbosacral radiculopathy.Recent findingsA medical literature search was conducted using MEDLINE, OVID, PubMed, EMBASE, and MDConsult for articles published from 1 December 20
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- 2005
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44. Nonoperative management of postoperative neck pain following a fusion
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Michael J. DePalma, Curtis W. Slipman, Amit Bhargava, Steven C. Ludwig, and Daniel E. Gelb
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medicine.medical_specialty ,Neck pain ,business.industry ,medicine ,Surgery ,Nonoperative management ,medicine.symptom ,business - Published
- 2005
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45. Transforaminal Cervical Blood Patch for the Treatment of Post–Dural Puncture Headache
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Kingsley R. Chin, Omar El Abd, Amit Bhargava, Michael J. DePalma, and Curtis W. Slipman
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Adult ,medicine.medical_specialty ,Post-dural-puncture headache ,Treatment outcome ,Physical Therapy, Sports Therapy and Rehabilitation ,Degenerative disc disease ,Shoulder Pain ,medicine ,Humans ,Epidural blood patch ,Neck pain ,Neck Pain ,Epidural steroid ,business.industry ,Rehabilitation ,Headache ,medicine.disease ,Surgery ,Treatment Outcome ,medicine.anatomical_structure ,Back Pain ,Anesthesia ,Cervical Vertebrae ,Female ,medicine.symptom ,business ,Blood Patch, Epidural ,Cervical vertebrae - Abstract
A 40-yr-old woman received a series of three interlaminar epidural steroid injections for the treatment of axial neck pain secondary to degenerative disc disease. Immediately after her third injection, she experienced symptoms of a dural puncture-induced headache. This headache persisted on a daily basis for 3 mos, despite two epidural blood patches using an interlaminar approach, which was finally completely abated with a transforaminal blood patch. The headache was immediately relieved and remained alleviated through the follow-up interval of 1 yr. In this patient, a fluoroscopically guided transforaminal epidural blood patch proved to be more effective than the classic blind interlaminar approach in the treatment of post-dural puncture headache.
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- 2005
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46. A novel technique for recording from the serratus anterior
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Ernest W. Johnson, Vivek Kadyan, William S. Pease, and Michael J. DePalma
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Adult ,Male ,Neural Conduction ,Axillary lines ,Action Potentials ,Motor nerve ,Intercostal Muscles ,Physical Therapy, Sports Therapy and Rehabilitation ,Electromyography ,Reference Values ,Thoracic Nerves ,Reaction Time ,medicine ,Humans ,medicine.diagnostic_test ,business.industry ,Rehabilitation ,Anatomy ,medicine.disease ,Long thoracic nerve ,Electric Stimulation ,Compound muscle action potential ,Axilla ,medicine.anatomical_structure ,Peripheral neuropathy ,Female ,business - Abstract
DePalma MJ, Pease WS, Johnson EW, Kadyan V. A novel technique for recording from the serratus anterior. Objective To design an electrodiagnostic technique by which to accurately record the serratus anterior compound muscle action potential (CMAP). Design Observational study. Setting Academic electromyography laboratory. Participants Fifteen healthy volunteers. Interventions The long thoracic nerve was stimulated by using a standard bipolar surface electrode in the axilla, just anterior to the midaxillary line. The serratus anterior CMAP was recorded by using a self-adhesive, 8.0×0.5cm, ring electrode as the E1 placed across the serratus anterior interdigitations starting at the nipple level. A self-adhesive, motor (1×1cm) electrode was used as E2 and placed over the seventh rib. A standard self-adhesive ground electrode was placed over the inferior region of the latissimus dorsi. Main outcome measures Distal motor latency (DML), and CMAP amplitude and duration. Results After removing 2 outliers, the results are reported as the mean ± 1.96 standard deviations. Right long thoracic DML was 2.2±1.0ms and the left was 2.3±0.9ms, with a side-to-side mean difference of 0.3±0.4ms. The right serratus CMAP amplitude was 3.8±3.9mV and the left was 3.9±3.7mV, with a side-to-side mean difference of 0.6±1.2mV. Statistical analysis did not reveal a significant side-to-side difference for DML or CMAP amplitude. Both sides were combined to form a single set of trials for DML and CMAP amplitude. The mean DML became 2.2±0.7ms, and the CMAP amplitude was 3.5±1.9mV. The CMAP duration was 14.5±4.3ms on the right and 14.5±4.1ms on the left. A significant, positive correlation existed between height and DML ( P Conclusions Our latency, side-to-side comparisons and amplitude data were consistent with other motor nerve conduction findings in the literature. Stimulating the long thoracic nerve in the axilla will provide a reliable technique to aid in the diagnosis and treatment of long thoracic neuropathy.
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- 2005
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47. An instance of an atypical intraspinal cyst presenting as S1 radiculopathy: a case report and brief review of pathophysiology11No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the authors(s) or upon any organization with which the author(s) is/are associated
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Jeffrey A. Strakowski, Eiran M Mandelker, Michael J. DePalma, and William R Zerick
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medicine.medical_specialty ,business.industry ,Rehabilitation ,Zygapophyseal Joint ,Physical Therapy, Sports Therapy and Rehabilitation ,Spondylolysis ,medicine.disease ,Pathophysiology ,Surgery ,Lumbar ,Radicular pain ,Orthopedic surgery ,medicine ,Cyst ,business ,Complication - Abstract
Intraspinal cysts are rare, but typically they originate from a degenerate zygapophyseal joint. These cysts have been commonly referred to as juxtafacet cysts and occur concomitantly with lumbar and occasionally lower-limb radicular pain. Documented cases have shown pseudoarthroses developing from nonhealing pars defects. Histologic analyses have found synovial tissue within these fibrocartilaginous accumulations. We present a case of S1 radiculopathy indicated by an intraspinal pseudocyst arising as a complication of a chronic spondylolytic defect. A brief review of the related pathophysiology is also included.
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- 2004
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48. Therapeutic Selective Nerve Root Block in the Nonsurgical Treatment of Traumatically Induced Cervical Spondylotic Radicular Pain
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Curtis W. Slipman, Jason S. Lipetz, Michael J. DePalma, and Howard B. Jackson
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Adult ,Employment ,Male ,medicine.medical_specialty ,Nerve root ,Visual analogue scale ,Radiography ,Physical Therapy, Sports Therapy and Rehabilitation ,Physical examination ,Radiography, Interventional ,Spinal Osteophytosis ,Spinal Stenosis ,Patient satisfaction ,Surveys and Questionnaires ,medicine ,Humans ,Radiculopathy ,Physical Examination ,Whiplash Injuries ,Aged ,Pain Measurement ,Retrospective Studies ,Analgesics ,medicine.diagnostic_test ,business.industry ,Electrodiagnosis ,Rehabilitation ,Nerve Block ,Magnetic resonance imaging ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Magnetic Resonance Imaging ,Surgery ,Treatment Outcome ,Back Pain ,Patient Satisfaction ,Radicular pain ,Fluoroscopy ,Anesthesia ,Cervical Vertebrae ,Female ,business - Abstract
Objective To investigate the outcomes resulting from the use of fluoroscopically guided therapeutic selective nerve root block in the nonsurgical treatment of traumatically induced cervical spondylotic radicular pain. Design Retrospective study with independent clinical review. A total of 15 patients who met specific physical examination or electrodiagnostic criteria and failed to improve clinically after at least 4 wks of physical therapy were included. Each patient demonstrated a positive response to a fluoroscopically guided cervical selective nerve root block. Therapeutic selective nerve root blocks were administered in conjunction with physical therapy. Outcome measures included visual analog scale pain scores, employment status, medication usage, and patient satisfaction. Results Patients' symptom duration before diagnostic injection averaged 13.0 mos. An average of 3.7 therapeutic injections were administered. Follow-up data collection transpired at an average of 20.7 mos after discharge from treatment. An overall good or excellent outcome was observed in three patients (20.0%). Among those treated without surgery, a significant reduction (P = 0.0313) in pain score was observed at the time of follow-up. Six patients (40.0%) proceeded to surgery. Conclusions These initial and preliminary findings do not support the use of therapeutic selective nerve root block in the treatment of this challenging patient population with traumatically induced spondylotic radicular pain.
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- 2004
- Full Text
- View/download PDF
49. Patellar Tendinosis
- Author
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Michael J. DePalma and Robert H. Perkins
- Subjects
musculoskeletal diseases ,medicine.medical_specialty ,business.industry ,Tendinosis ,Jumper ,Physical Therapy, Sports Therapy and Rehabilitation ,musculoskeletal system ,medicine.disease ,Patellar tendon ,medicine ,Physical therapy ,Plyometrics ,Eccentric ,Orthopedics and Sports Medicine ,Tendinopathy ,business ,human activities ,Patellar tendon rupture ,Jumper's knee - Abstract
Patellar tendinopathy (jumper's knee) may affect athletes who engage in explosive lower-limb movements. An eccentric contraction of the quadriceps when landing after a jump may lead to acute patellar tendon rupture, the end-stage of patellar tendinopathy. Plain x-rays will usually confirm the diagnosis. Treatment centers around reducing the stress placed on the patellar tendon. Postoperative functional restoration and preventive measures must address biomechanic abnormalities that may predispose patients to disruptive patellar tendon strain. As this case report shows, counseling patients who have early-stage tendinopathy on appropriate flexibility and plyometric exercises may prevent more serious damage.
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- 2004
- Full Text
- View/download PDF
50. Detecting and Treating Shoulder Impingement Syndrome
- Author
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Michael J. DePalma and Ernest W. Johnson
- Subjects
musculoskeletal diseases ,medicine.medical_specialty ,Rehabilitation ,business.industry ,medicine.medical_treatment ,Physical Therapy, Sports Therapy and Rehabilitation ,musculoskeletal system ,Physical medicine and rehabilitation ,medicine.anatomical_structure ,Scapula ,Muscle dysfunction ,Subacromial impingement ,Shoulder Impingement Syndrome ,medicine ,Orthopedics and Sports Medicine ,Rotator cuff ,Shoulder joint ,Range of motion ,business - Abstract
The shoulder joint is most appropriately referred to as the “shoulder complex,” since its total range of motion depends on four interworking articulations. The scapula is central in proficient shoulder activity, and rotator cuff muscles will not operate optimally if the scapula is poorly positioned. Dynamic scapular stabilization requires coordinated muscular activity, and muscle dysfunction will lead to glenohumeral incongruity during overhead athletic activities. Lack of scapular protraction, upward rotation, and posterior tilting can lead to subacromial impingement. Pain inhibition and fatigue can also provoke altered muscle patterns, but rehabilitation exercises can address biomechanic deficiencies.
- Published
- 2003
- Full Text
- View/download PDF
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