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Leonardo Kapural,1 Jim Melton,2 Billy Kim,3 Priyesh Mehta,4 Abindra Sigdel,5 Alexander Bautista,6 Erika A Petersen,7 Konstantin V Slavin,8,9 John Eidt,10 Jiang Wu,11 Said Elshihabi,12 Jason Matthew Schwalb,13 H Edward Garrett Jr,14 Elias Veizi,15 Giancarlo Barolat,16 Ravi R Rajani,17 Peter C Rhee,18 Maged Guirguis,19 Nagy Mekhail20 1Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, NC, USA; 2Department of Vascular Surgery, Cardiovascular Health Clinic, Oklahoma City, OK, USA; 3Department of Vascular Surgery, The Surgical Clinic, Nashville, TN, USA; 4Department of Pain Medicine, Meta Medical Research Institute, Dayton, OH, USA; 5Department of Surgery, University of Louisville, Louisville, KY, USA; 6Department of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY, USA; 7Department of Neurosurgery, University of Arkansas, Little Rock, AR, USA; 8Department of Neurosurgery, University of Illinois at Chicago, Chicago, IL, USA; 9Department of Neurology, Jesse Brown VA Medical Center, Chicago, IL, USA; 10Department of Vascular Surgery, Baylor Scott and White Heart and Vascular Hospital Dallas, Dallas, TX, USA; 11Department of Anesthesiology & Pain Medicine, University of Washington Medical Center, Seattle, WA, USA; 12Department of Neurosurgery, Legacy Brain & Spine Surgical Center, Atlanta, GA, USA; 13Department of Neurosurgery, Henry Ford Medical Group, Detroit, MI, USA; 14Department of Vascular Surgery, University of Tennessee-Memphis, Memphis, TN, USA; 15Department of Pain Medicine, VA Northeast OH Healthcare System, Cleveland, OH, USA; 16Department of Neurosurgery, Barolat Neuroscience, Presbyterian/St Luke’s Medical Center, Denver, CO, USA; 17Department of Vascular Surgery, Emory University and Grady Memorial Hospital, Atlanta, GA, USA; 18Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA; 19Department of Interventional Pain Management, Ochsner Health System, New Orleans, LA, USA; 20Department of Pain Management, Cleveland Clinic, Cleveland, OH, USACorrespondence: Leonardo Kapural, Carolinas Pain Institute and Center for Clinical Research, 145 Kimel Park Dr #330, Winston-Salem, NC, 27103, USA, Email lkapuralmd@gmail.comPurpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain.Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥ 50% pain relief 30 min after treatment in ≥ 50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined.Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups.Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.Keywords: post-amputation pain, phantom limb pain, neuromodulation, peripheral nerve stimulation, high-frequency nerve block

Leonardo Kapural,1 Nemath Syed Shah,2 Zi-Ping Fang,2 Nagy Mekhail3 1Carolinas Pain Institute, Winston-Salem, NC, USA; 2Neuros Medical, Inc., Willoughby Hills, OH, USA; 3Evidence-Based Pain Management Research, Department of Pain Management, Cleveland Clinic, Cleveland, OH, USACorrespondence: Leonardo Kapural, Carolinas Pain Institute, 145 Kimel Park Drive, Winston-Salem, NC, 27023, USA, Tel +1 336-765-6181, Email lkapuralmd@gmail.comBackground: Chronic pain that follows amputation of a limb is reported as “one of the most severe pains in the human experience,” due to the magnitude of tissue injury and the multiple potential of pain generators at the local peripheral, spinal, and cortical levels. The Altius® System was developed to deliver high-frequency nerve block (HFNB) therapy via a cuff electrode applied to the peripheral nerve(s) and an implantable pulse generator. We report a novel clinical trial design for the first study of an active-implantable medical device in subjects with lower-limb post-amputation pain utilizing a multicenter, double-blinded, randomized, active-sham controlled clinical study protocol called QUEST, which is an ongoing investigational device exemption study to support United States Food and Drug Administration approval.Methods: The study enrollment of 180 subjects was completed in September 2021. Subjects were randomized 1:1 to the treatment group or the active-sham control group for the 3-month primary effectiveness and safety endpoints. After month 3, the active-sham control program group crossed over to the treatment program group and all subjects continued to the 12-month study endpoint. Study effectiveness success is determined by a superiority test between responder rates in the treatment and control groups at 3 months. A responder is defined as someone who experiences a 50% or greater reduction in pain scores – after a 30-minute treatment session – for more than 50% of all pain episodes in which the treatment was used.Discussion: The QUEST study design employs an active-sham control group to objectively assess the effectiveness of HFNB therapy. Additionally, the electronic diary repeated measures data collection in QUEST is expected to reduce the intra-subject variation typically observed in pain treatment studies. Finally, the longitudinal measurement of health-related quality of life and use of pain medication may, for example, show effectiveness in reducing opioid use over time.Keywords: post-amputation pain, phantom pain, chronic pain, high frequency nerve block, double-blind method, randomized controlled trial, repeated measures

Coccygodynia is painful condition localized in the region of the coccyx. In most cases a traumatic etiology is present. In the idiopathic form other causes such as infections and tumor have to be excluded. Coccygodynia can also be the result of pain referred from visceral structures due to conditions such as disorders of the rectum, the colon sigmoideum, and the urogenital system. In case of a traumatic etiology the diagnosis is made based on the typical medical history whereby the pain is provoked by prolonged sitting and cycling. Lateral images of the coccyx are always indicated. The same is true for manual examination of the coccyx. In case of absence of provocation of the coccygeal pain by prolonged sitting and manual examination neurological causes such as lumbar disc hernias are a possible reason for the coccygodynia. In the acute phase the first choice of treatment are NSAIDs. Treatment for patients with severe pain in the chronic phase consists of manual therapy and/or a local injection of local anesthetic and corticosteroid into the painful segment (2 C+). Other interventional treatments such as intradiscal injections, ganglion impar block, radiofrequency treatment and caudal block are advised only under study conditions (0). Coccygectomy is not recommended because of long-term moderate results and the chance of major complications. [ABSTRACT FROM AUTHOR]

An estimated 40% of chronic lumbosacral spinal pain is attributed to the discus intervertebralis. Degenerative changes following loss of hydration of the nucleus pulposus lead to circumferential or radial tears within the annulus fibrosus. Annular tears within the outer annulus stimulate the ingrowth of blood vessels and accompanying nociceptors into the outer and occasionally inner annulus. Sensitization of these nociceptors by various inflammatory repair mechanisms may lead to chronic discogenic pain. The current criterion standard for diagnosing discogenic pain is pressure-controlled provocative discography using strict criteria and at least one negative control level. The strictness of criteria and the adherence to technical detail will allow an acceptable low false positive response rate. The most important determinants are the standardization of pressure stimulus by using a validated pressure monitoring device and avoiding overly high dynamic pressures by the slow injection rate of 0.05 mL/s. A positive discogram requires the reproduction of the patient's typical pain at an intensity of > 6/10 at a pressure of < 15 psi above opening pressure and at a volume less than 3.0 mL. Perhaps the most important and defendable response is the failure to confirm the discus is symptomatic by not meeting this strict criteria. Various interventional treatment strategies for chronic discogenic low back pain unresponsive to conservative care include reduction of inflammation, ablation of intradiscal nociceptors, lowering intranuclear pressure, removal of herniated nucleus, and radiofrequency ablation of the nociceptors. Unfortunately, most of these strategies do not meet the minimal criteria for a positive treatment advice. In particular, single-needle radiofrequency thermocoagulation of the discus is not recommended for patients with discogenic pain (2 B−). Interestingly, a little used procedure, radiofrequency ablation of the ramus communicans, does meet the (2 B+) level for endorsement. There is currently insufficient proof to recommend intradiscal electrothermal therapy (2 B±) and intradiscal biacuplasty (0). It is advised that ozone discolysis, nucleoplasty, and targeted disc decompression should only be performed as part of a study protocol. Future studies should include more strict inclusion criteria. [ABSTRACT FROM AUTHOR]

Persistent idiopathic facial pain, previously known as atypical facial pain, is described as a persistent facial pain that does not have the classical characteristics of cranial neuralgias and for which there is no obvious cause (International Classification of Headache Disorders in 2004). According to these criteria, the diagnosis is possible if the facial pain is localized, present daily, and throughout all or most of the day. By definition, neurological and physical examination findings in persistent idiopathic facial pain should be normal. Forming a diagnosis is not simple and follows a process of elimination of other causes of facial pain. The precise incidence is unknown. The affliction is seen primarily in older adults and rarely in children. The pathophysiology is unknown. In persistent idiopathic facial pain, there is no abnormal processing of somatosensory stimuli in the pain area or facial area of the primary somatosensory cortex of the brain. The treatment is difficult and often requires a multidisciplinary approach. The most important part of the treatment is psychological counseling and pharmacological therapy. Pharmacological treatment with tricyclic antidepressants and anti-epileptic drugs can be tried. The conservative, pharmacological treatment with amitryptiline is the primary choice. Venlafaxine and fluoxetine treatment can also be considered. When the pharmacological treatment fails, pulsed radiofrequency treatment of the ganglion pterygopalatinum (sphenopalatinum) can be considered (2 C+). [ABSTRACT FROM AUTHOR]

Cluster headache is a strictly unilateral headache that is associated with ipsilateral cranial autonomic symptoms and usually has a circadian and circannual pattern. Prevalence is estimated at 0.5 to 1.0/1,000. The diagnosis of cluster headache is made based on the patient's case history. There are two main clinical patterns of cluster headache: the episodic and the chronic. Episodic is the most common pattern of cluster headache. It occurs in periods lasting 7 days to 1 year and is separated by at least a 1-month pain-free interval. The attacks in the chronic form occur for more than 1 year without remission periods or with remission periods lasting less than 1 month. Conservative therapy consists of abortive and preventative remedies. Ergotamines and sumatriptan injections, sublingual ergotamine tartrate administration, and oxygen inhalation are effective abortive therapies. Verapamil is an effective and the safest prophylactic remedy. When pharmacological and oxygen therapies fail, interventional pain treatment may be considered. The effectiveness of radiofrequency treatment of the ganglion pterygopalatinum and of occipital nerve stimulation is only evaluated in observational studies, resulting in a 2 C+ recommendation. In conclusion, the primary treatment is medication. Radiofrequency treatment of the ganglion pterygopalatinum should be considered in patients who are resistant to conservative pain therapy. In patients with cluster headache refractory to all other treatments, occipital nerve stimulation may be considered, preferably within the context of a clinical study. [ABSTRACT FROM AUTHOR]

With an increased knowledge of neural anatomy and technologic improvement, radiofrequency ablation (RFA) became an often-used technique for the pain control over an extended time period. Today, RFA is used safely for spinal pains of facet or discogenic origin, sympathetically maintained pain, and other pains of neural origin. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Acupuncture has been used as a therapy for various gastrointestinal disorders, including irritable bowel syndrome (IBS). However, there is scant information on the effect of acupuncture on gut physiology. The purpose of this study was to evaluate the effect of transcutaneous electrical acustimulation (TEAS) on rectal tone, compliance and perception in IBS patients. METHODS: Seven patients with diarrhea-predominant IBS were studied during control, sham stimulation and acupoints (ST36 and P6) stimulation periods. Rectal tone, compliance and perception to rectal balloon distension were assessed with a barostat apparatus. RESULTS: Acustimulation at ST36 and P6, but not sham stimulation, significantly increased the threshold of rectal sensation of gas, desire to defecate and pain, as compared to control period. However, rectal tone and compliance were not significantly affected during TEAS. CONCLUSIONS: TEAS, at the above acupoints, can reduce rectal sensitivity in IBS patients. The effect is not modulated by changes in rectal biomechanics. [ABSTRACT FROM AUTHOR]

Objective: The multicenter, randomized, double-blinded, active-sham controlled trial (high-freQUEncy nerve block for poST amputation pain [QUEST]) was conducted to show the safety and efficacy of a novel, peripherally placed high-frequency nerve block (HFNB) system in treating chronic postamputation pain (PAP) in patients with lower limb amputations. The primary outcomes from QUEST were reported previously. This study presents the long-term, single-cross-over, secondary outcomes of on-demand HFNB treatment for chronic PAP., Materials and Methods: After the three-month randomized period, subjects in the active-sham group were crossed over to receive therapy for 12 months. Subjects self-administered HFNB therapy as needed and reported their pain (numerical rating scale [NRS]; range, 1-10) before and 30 and 120 minutes after each treatment. Pain medication use was reported throughout the study. Pain-days per week and quality of life (QOL) were assessed using the Brief Pain Inventory (BPI). Adverse events (AEs) were recorded for all subjects implanted for 12 months., Results: Of 180 subjects implanted in QUEST, 164 (91%) were included in the cross-over period, and 146 (82%) completed follow-up. By month 12, average NRS pain in the combined cohort was reduced by 2.3 ± 2.2 points (95% CI, 1.7-2.8; p < 0.0001) 30 minutes after treatment and 2.9 ± 2.4 points (95% CI, 2.2-3.6; p < 0.0001) 120 minutes after treatment. Mean pain-days per week were significantly reduced (-3.5 ± 2.7 days; p < 0.001), and subject daily opioid use was reduced by 6.7 ± 29.0 morphine equivalent dose from baseline to month 12 (p = 0.013). Mean BPI-interference scores (QOL) improved by 2.7 ± 2.7 points from baseline (p < 0.001). The incidence of nonserious AEs and serious AEs was 72% (130/180) and 42% (76/180), respectively; serious device-related AEs occurred in 15 of 180 subjects (8%)., Conclusion: Overall, HFNB delivered directly to the damaged peripheral nerve provided sustained, on-demand relief of acute PAP exacerbations, reduced opioid utilization, and improved QOL for patients with lower limb amputations with chronic PAP., Competing Interests: Conflict of Interest Leonardo Kapural reports grants and/or personal fees from Biotronik, Medtronic, Nevro, Presidio, Saluda Medical, Nalu Medical, and Gimer Medical. Erika A. Petersen reports grants and/or personal fees from Biotronik, Medtronic Neuromodulation, Nevro, Presidio Medical, Saluda, and SPR, outside the submitted work. Jason M. Schwalb reports grants from Medtronic, SetPoint, Nevro, MeiraGTX; and salary support for role as codirector of the Michigan Spine Surgery Improvement Collaborative, paid directly to employer from Blue Cross Blue Shield of Michigan, outside the submitted work. Konstantin V. Slavin reports institutional research and education grants from Medtronic, Abbott, Boston Scientific, Neuros, and Stryker; personal and institutional support from Abbott, Biotronik, Integer, Medtronic, Saluda, Stimwave, Synergia, Thermaquil, and WISE; and participation on a Data Safety Monitoring Board for Abbott and Nurami. The remaining authors reported no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)