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Timothy Deer,1,* Robert Heros,2,* Edward Tavel,3 Sayed Wahezi,4 Robert Funk,5 Patrick Buchanan,6 Anne Christopher,7 Jacqueline Weisbein,8 Christopher Gilligan,9 Denis Patterson,10 Ajay Antony,11 Mohab Ibrahim,12 Nathan Miller,13 Keith Scarfo,14 Gayle Johnson,15 Thadchaigeni Panchalingam,15 Udoka Okaro,15 James Yue16 1Pain Management, The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 2Pain Management, Spinal Diagnostics, Tualatin, OR, USA; 3Pain Management, Clinical Trials of South Carolina, Charleston, SC, USA; 4Pain Management, Montefiore Medical Center, Bronx, NY, USA; 5Pain Management, Indiana Spine Group, Indianapolis, IN, USA; 6Pain Management, Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA; 7Pain Management, Saint Louis Pain Consultants, Chesterfield, MO, USA; 8Pain Management, Napa Valley Orthopedic Medical Group, Napa, CA, USA; 9Pain Management, Robert Wood Johnson University Hospital, New Brunswick, NJ, USA; 10Pain Management, Nevada Advanced Pain Specialists, Reno, NV, USA; 11Pain Management, the Orthopedic Institute, Gainesville, FL, USA; 12Pain Management, Coastal Pain & Spinal Diagnostics Medical Group, Carlsbad, CA, USA; 13Pain Management, Banner University Medical Center, Tucson, AZ, USA; 14Pain Management, Rhode Island Hospital, Providence, RI, USA; 15Neuromodulation, Abbott Labs, Austin, TX, USA; 16Orthopaedic spine Surgery, Connecticut Orthopedics, Hamden, CT, USA*These authors contributed equally to this workCorrespondence: Timothy Deer, Pain Management, The Spine and Nerve Center of the Virginias, 400 Court Street, Suite 100, Charleston, WV, 25301, USA, Tel +1 304 347 – 6120, Fax +1 304 347 – 6126, Email doctdeer@aol.comAim: Low Back Pain (LBP) is a prevalent condition. Spinal cord stimulation (SCS) has emerged as a more effective, long-term treatment compared to conventional medical management (CMM). The DISTINCT study enrolled and randomized chronic LBP patients with no indication of traditional spine surgery. This analysis focuses comparing study outcomes on patients initially randomized to receive CMM treatment and subsequently crossed over to SCS after 6 months.Purpose: To compare the therapeutic effectiveness and cost-efficiency of passive recharge burst SCS to CMM.Patients and Methods: A total of 269 patients were enrolled with 162 randomly assigned to SCS and 107 to CMM. The DISTINCT study design allowed a crossover to the alternative treatment arm after 6 months. Patients underwent a trial and received a permanent implant if they reported ≥ 50% pain reduction. Outcome analysis included pain (NRS), disability (ODI), catastrophizing (PCS), quality of life (PROMIS-29) and health care utilization.Results: Seventy out of eighty-one patients opted to cross over to trial SCS at 6M with 94% (66/70) undergoing a trial. Among those, 88% (58/66) reported a ≥ 50% or more pain relief and 55 received a permanent implant. At 12M visit, 71.4% reported a ≥ 50% pain improvement sustained at the 18M visit, with 24.5% (12/49) indicating a ≥ 80% improvement. Disability reductions (79% meeting the minimally important difference of a 13-point decrease), decreased catastrophizing, and significant improvements in all PROMIS-29 domains were noted. Furthermore, 42% of the patients reported decreased or discontinued opioid usage. Clinical benefits at the 12M visit were sustained through the 18M visit accompanied by a significant reduction in healthcare utilization and a $1214 cost savings.Conclusion: SCS demonstrates superior, long-term performance and safety outcomes compared to CMM therapy in LBP patients who received both CMM and SCS therapy. Additionally, SCS patients experienced reduced healthcare resource utilization and lower costs compared to those receiving CMM.Keywords: DISTINCT, low back pain, BurstDR, spinal cord stimulation, healthcare utilization, persistent spinal pain syndrome, neuromodulation

David W Lee,1 Scott Pritzlaff,2,3 Michael J Jung,2,3 Priyanka Ghosh,4 Jonathan M Hagedorn,5 Jordan Tate,6 Keith Scarfo,7 Natalie Strand,8 Krishnan Chakravarthy,9,10 Dawood Sayed,11 Timothy R Deer,12 Kasra Amirdelfan13 1Fullerton Orthopedic Surgery Medical Group, Fullerton, CA, 92831, USA; 2University of California, Davis; 3Division of Pain Medicine, Sacramento, CA, USA; 4ReMedy Medical Group, San Francisco, CA, USA; 5Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA; 6Alliance Spine and Pain Centers, Canton, GA, USA; 7Warren Alpert Medical School of Brown University Department of Neurosurgery - Norman Prince Spine Institute, Rhode Island Hospital, Providence, RI, USA; 8Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Phoenix, AZ, USA; 9University of California, San Diego; 10Division of Pain Medicine, San Diego, CA, USA; 11University of Kansas Medical Center, Kansas City, KS, USA; 12The Spine and Nerve Center of the Virginias, Inc., Charleston, WV, USA; 13IPM Medical Group, Inc., Walnut Creek, CA, USACorrespondence: David W LeeFullerton Orthopedic Surgery Medical Group, 680 Langsdorf Dr Suite 103, Fullerton, CA, 92831, USATel +1 714-879-0050Email lee.davidw@gmail.comAbstract: Radiofrequency neurotomy (RFN), also known as radiofrequency ablation (RFA), is a common interventional procedure used to treat pain from an innervated structure. RFN has historically been used to treat chronic facet-joint mediated pain. The use of RFN has more recently expanded beyond facet-joint mediated pain to peripherally innervated targets. In addition, there has also been the emergence of different radiofrequency modalities, including pulsed and cooled RFN. The use of RFN has been particularly important where conservative and/or surgical measures have failed to provide pain relief. With the emergence of this therapeutic option and its novel applications, the American Society of Pain and Neuroscience (ASPN) identified the need for formal evidence-based guidance. The authors formed a multidisciplinary work group tasked to examine the latest evidence-based medicine for the various applications of RFN, including cervical, thoracic, lumbar spine; posterior sacroiliac joint pain; hip and knee joints; and occipital neuralgia. Best practice guidelines, evidence and consensus grading were provided for each anatomical target.Keywords: radiofrequency neurotomy, radiofrequency ablation, pulsed ablation, cooled ablation, sacroiliac joint neurotomy, peripheral joint neurotomy, occipital neuralgia, chronic pain

Alexios G Carayannopoulos,1,* Keith A Scarfo,2,* Alaa Abd-Elsayed,3 Augustine C Lee4 1Department of Physical Medicine and Rehabilitation, Rhode Island Hospital, Brown University Medical School, Providence, RI, USA; 2Department of Neurosurgery, Rhode Island Hospital, Brown University Medical School, Providence, RI, USA; 3Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; 4Department of Physical Medicine and Rehabilitation, Tufts University School of Medicine, Boston, MA, USA*These authors contributed equally to this workCorrespondence: Alexios G Carayannopoulos, Department of Physical Medicine and Rehabilitation, Rhode Island Hospital, Brown University Medical School, Providence, RI, 02903, USA, Tel +1 401-793-9837, Fax +1 401-793-9143, Email acarayannopoulos@lifespan.orgBackground: Spinal cord stimulation (SCS) is an important option for patients with chronic neuropathic pain. In the United States, a successful SCS trial determines eligibility for SCS implant. Metrics to determine success are often self-reported and subjective, which may limit achievement of patient goals. This study aimed to assess whether patients undergoing SCS implant after successful trial felt that use of external accelerometry prior to implant was a useful educational tool to objectively appraise function and achievement of treatment goals.Methods: This was a single center, prospective, pilot study. Sixteen subjects with persistent spinal pain syndrome type 2 underwent a percutaneous SCS trial. Five subjects did not have a successful trial, one expired after the SCS trial, before implant, and one dropped out prior to completion of post-implant follow-up visits. Nine subjects underwent SCS implant and completed the required follow-up visits. All subjects were provided an Actigraph GT3X external accelerometer, worn 7 days prior to the trial to determine baseline physical activity and during the 7-day trial to assess for change in activity from baseline. Results were shared with subjects to individualize goals for therapy. Goal attainment was assessed at 1, 3, and 6 months after implant. Subjects wore the accelerometer again 24 hours before visits to update progress in meeting treatment goals. The primary outcome was satisfaction with using accelerometry as an educational tool to appraise function and guide treatment goals for SCS therapy. Secondary outcomes included physical activity, as captured via accelerometry, as well as validated patient-reported measures of pain severity, physical functioning, and quality-of-life.Results: Eight of nine subjects were satisfied with accelerometry as an educational tool. Secondary outcomes were not reliably assessed due to poor stewardship and study execution.Conclusion: External accelerometry may assist patients in developing individualized functional treatment goals for SCS therapy.Keywords: low back pain, accelerometer, physical activity, spinal cord stimulator, patient

Background: Low back pain (LBP) is a highly prevalent, disabling condition affecting millions of people. Patients with an identifiable anatomic pain generator and resulting neuropathic lower extremity symptoms often undergo spine surgery, but many patients lack identifiable and/or surgically corrective pathology. Nonoperative treatment options often fail to provide sustained relief. Spinal cord stimulation (SCS) is sometimes used to treat these patients, but the lack of level 1 evidence limits its widespread use and insurance coverage. The DISTINCT RCT study evaluates the efficacy of passive recharge burst SCS compared to conventional medical treatment (CMM) in alleviating chronic, refractory axial low back pain., Methods: This prospective, multicenter, randomized, study with an optional 6-month crossover involved patients who were not candidates for lumbar spine surgery. The primary and secondary endpoints evaluated improvements in low back pain intensity (NRS), back pain-related disability (ODI), pain catastrophizing (PCS), and healthcare utilization. Patients were randomized to SCS therapy or CMM at 30 US study sites., Results: The SCS arm reported an 85.3% NRS responder rate (≥ 50% reduction) compared to 6.2% (5/81) in the CMM arm. After the 6M primary endpoint, SCS patients elected to remain on assigned therapy and 66.2% (49/74) of CMM patients chose to trial SCS (crossover). At the 12M follow-up, SCS and crossover patients reported 78.6% and 71.4% NRS responder rates. Secondary outcomes indicated significant improvements in ODI, PCS, and reduced healthcare utilization. Six serious adverse events were reported and resolved without sequelae., Conclusion: DISTINCT chronic low back pain patients with no indication for corrective surgery experienced a significant and sustained response to burst SCS therapy for up to 12 months. CMM patients who crossed over to the SCS arm reported profound improvements after 6 months. This data advocates for a timely consideration of SCS therapy in patients unresponsive to conservative therapy., Competing Interests: One or more of the authors declare financial or professional relationships on ICMJE-NASSJ disclosure forms., (© 2024 The Author(s).)

Objective: Spinal cord stimulation (SCS) is effective for relieving chronic intractable pain conditions. The Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain study evaluates the effectiveness of SCS compared with conventional medical management (CMM) in the treatment of chronic low back pain in patients who had not undergone and were not candidates for lumbar spine surgery., Methods and Materials: Patients were randomized to passive recharge burst therapy (n = 162) or CMM (n = 107). They reported severe pain and disability for more than a decade and had failed a multitude of therapies. Common diagnoses included degenerative disc disease, spondylosis, stenosis, and scoliosis-yet not to a degree amenable to surgery. The six-month primary end point compared responder rates, defined by a 50% reduction in pain. Hierarchical analyses of seven secondary end points were performed in the following order: composite responder rate (numerical rating scale [NRS] or Oswestry Disability Index [ODI]), NRS, ODI, Pain Catastrophizing Scale responder rate, Patient Global Impression of Change (PGIC) responder rate, and Patient-Reported Outcome Measure Information System-29 in pain interference and physical function., Results: Intention-to-treat analysis showed a significant difference in pain responders on NRS between SCS (72.6%) and CMM (7.1%) arms (p < 0.0001). Of note, 85.2% of those who received six months of therapy responded on NRS compared with 6.2% of those with CMM (p < 0.0001). All secondary end points indicated the superiority of burst therapy over CMM. A composite measure on function or pain relief showed 91% of subjects with SCS improved, compared with 16% of subjects with CMM. A substantial improvement of 30 points was observed on ODI compared with a

We previously showed that a vector:lipid delivery system, comprised of a plasmid DNA vector and cationic lipid (lipoplex), when injected into the cerebrospinal fluid (CSF) of rats can deliver reporter genes in vivo efficiently and with widespread expression to the Central Nervous System (CNS). To further characterize this delivery system, we now present experiments that demonstrate the in vivo time-to-peak expression of the reporter gene, firefly luciferase. We infused a formulated lipoplex containing the lipid MLRI [dissymmetric myristoyl (14:0) and lauroyl (12:1) rosenthal inhibitor-substituted compound formed from the tetraalkylammonium glycerol-based DORI] and pNDluc, a luciferase vector, into CSF in the cisterna magna (CM) of the rat. Luciferase activity was followed over time by bioluminescence imaging after injection of luciferin. Our results show that luciferase activity in the CNS of rats is widespread, peaks 72 hours after injection into CM and can be detected in vivo for at least 7-10 days after peak expression. We further show that in contrast to injection into CSF, enzyme activity is not widely distributed after injection of the vector into brain parenchyma, emphasizing the importance of CSF delivery to achieve widespread vector distribution. Finally, we confirm the distribution of firefly luciferase in brain by immunohistochemical staining from an animal that was euthanized at the peak of enzyme expression.

Background: Patient-controlled analgesia is associated with potentially fatal opioid-related respiratory depression. Opioids are a well-recognized cause of respiratory depression. However, in the postoperative patient, unrecognized pulmonary disease may lead to retention of carbon dioxide, which is further antagonized by opioids and may lead to life-threatening respiratory depression. Therefore, using a method that would provide earlier warnings for respiratory problems could improve patient outcomes., Objective: To assess the efficacy of monitoring postoperative patients who were receiving patient-controlled opioid therapy with capnography modules in addition to the routine use of pulse oximetry to monitor ventilatory status and generate alerts when respiratory parameters exceed hospital-established limits., Method: Postoperative patients receiving patient-controlled analgesia were compared in relation to the use of pulse oximetry and capnography modules and their ability to generate alerts about abnormal respiratory parameters. A total of 634 patients receiving patient-controlled analgesia therapy were studied, of whom 239 (38%) received hydromorphone, 297 (47%) received morphine, and 98 (15%) received fentanyl. All 9 patients experiencing respiratory depression received supplemental oxygen., Results: Of the 634 patients studied, 9 (1.4%) experienced respiratory depression by bradypnea (<6 breaths per minute). Six (67%) events were related to hydromorphone and 3 (33%) were related to morphine. In 7 (78%) events, there was no basal infusion rate and the saturation of peripheral oxygen was >92%. All respiratory depression events occurred within the first 24 hours of patient-controlled analgesia therapy. In all cases, capnography, but not pulse oximetry, alerted the nurse to impending respiratory depression., Conclusions: Capnography was more effective than pulse oximetry in providing early warning of respiratory depression in patients receiving supplemental oxygen. Capnographic monitoring and automatic pausing of patient-controlled analgesia improved postoperative outcomes in situations that could have otherwise been fatal. Use of capnography improved clinician confidence that opioid dosing could be safely continued in postoperative patients for more effective pain management.