Julien Vaisman

Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: long-term results from a randomized, multicenter, double-blinded, controlled study.

Background Recent studies evaluated short-term efficacy and safety of peripheral nerve stimulation (PNS) of the occipital nerves for managing chronic migraine. We present 52-week safety and efficacy results from an open-label extension of a randomized, sham-controlled trial. Methods In this institutional review board-approved, randomized, multicenter, double-blinded study, patients were implanted with a neurostimulation system, randomized to an active or control group for 12 weeks, and received open-label treatment for an additional 40 weeks. Outcomes collected included number of headache days, pain intensity, migraine disability assessment (MIDAS), Zung Pain and Distress (PAD), direct patient reports of headache pain relief, quality of life, satisfaction and adverse events. Statistical tests assessed change from baseline to 52 weeks using paired t-tests. Intent-to-treat (ITT) analyses of all patients (N = 157) and analyses of only patients who met criteria for intractable chronic migraine (ICM; N = 125) were performed. Results Headache days were significantly reduced by 6.7 (±8.4) days in the ITT population (p < 0.001) and by 7.7 (±8.7) days in the ICM population (p < 0.001). The percentages of patients who achieved a 30% and 50% reduction in headache days and/or pain intensity were 59.5% and 47.8%, respectively. MIDAS and Zung PAD scores were significantly reduced for both populations. Excellent or good headache relief was reported by 65.4% of the ITT population and 67.9% of the ICM population. More than half the patients in both cohorts were satisfied with the headache relief provided by the device. A total of 183 device/procedure-related adverse events occurred during the study, of which 18 (8.6%) required hospitalization and 85 (40.7%) required surgical intervention; 70% of patients experienced an adverse event. Conclusion Our results support the 12-month efficacy of PNS of the occipital nerves for headache pain and disability associated with chronic migraine. More emphasis on adverse event mitigation is needed in future research. Trial registration: Clinical trials.gov (NCT00615342).

The treatment of medically intractable trigeminal autonomic cephalalgia with supraorbital/supratrochlear stimulation: a retrospective case series.

Introduction:  This is a retrospective case series of five patients with intractable trigeminal autonomic cephalalgia (TAC) who were implanted with a supraorbital/supratrochlear neuromodulation system.

Subcutaneous Peripheral Nerve Stimulation With Paddle Lead for Treatment of Low Back Pain: Case Report

Introduction. Peripheral nerve stimulation has become a useful tool in neuromodulation in the treatment of chronic and intractable pain syndromes. Method. While most of the reports in the literature describe the use of a subcutaneously placed small diameter cylindric lead, we present a case report of a 37‐year‐old man who did not have adequate axial back stimulation with such a lead. Conclusion. He had excellent stimulation and reduction of his pain after the device was replaced with an insulated subcutaneous paddle lead.

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation.

In this study, we analyze device‐ and procedure‐related adverse events (AEs) from a recent prospective, multicenter, double‐blinded controlled study that utilized peripheral nerve stimulation (PNS) of occipital nerves for management of chronic migraine.

Treatment of chronic, intractable pain with a conventional implantable pulse generator: a meta-analysis of 4 clinical studies.

Objective:To provide further short-term (6 mo) and long-term (1 y) evidence for the use of spinal cord stimulation (SCS) with a conventional implantable pulse generator in the management of chronic, intractable pain. Materials and Methods:We conducted a meta-analysis of 4 prospective, multicenter studies that collected outcome data from patients implanted with SCS to treat chronic pain of the trunk and/or limbs (Genesis IPG system). Two of these were conducted as long-term studies lasting 1 year, and 2 as shorter term studies lasting 6 months. A total of 300 patients from 28 investigational sites were prospectively evaluated for efficacy at 3 months after implant and safety at 6 months after implant. None of the sites participated in more than one study. Outcome measures included patient-reported percent of pain relief, patient satisfaction, quality of life improvement, pain evaluation (0 to 10 rating), pain relief rating, Short-Form McGill Pain Questionnaire, visual analog scale, the Short Form-36, and the total number of adverse events (AEs). Results:At 3 months after implantation of the permanent system, 75.4% of the patients (190/252) reported a 50% or greater pain relief as determined by the patient-reported degree of pain relief. Similarly, assessment of patient satisfaction with SCS therapy showed that 86.1% of patients (217/252) in all 4 studies were satisfied or very satisfied with the therapy at 3 months. In the 2 long-term studies, 80.9% of patients (140/173) were satisfied or very satisfied with the therapy at the 1-year evaluation point. Quality-of-life (QoL) data indicated that at 3 months after implant, 77.8% of patients (196/252) reported QoL as improved or greatly improved. Similarly, QoL was improved or greatly improved for 74.0% patients in the long-term study at 1 year (128/173). In the safety analysis, AEs were reviewed for all 4 studies. A total of 190 AEs were reported in 117 of 300 patients during all studies. Conclusions:This analysis provides further evidence of the safety and effectiveness of SCS in treating chronic intractable pain of the trunk and/or limbs. Specifically, it underscores a high level of effectiveness and acceptable safety concerns in the use of nonrechargeable SCS devices.

Post-surgical spine syndrome

Dear Sir, It is our view that the diagnostic terms post laminectomy syndrome (ICD-9 code 722.8) or failed back syndrome[1,4,8] are inaccurate, misleading, can be construed as disparaging, and should be discarded. We propose that these terms should be replaced with Post-surgical Spine Syndrome (PSSS). Implicit in the terms is that pain and disability following spinal surgery is the result of failed or unsuccessful surgery. Not infrequently, patients report that following surgery, “my leg pain is gone, but my back still hurts.” A significant number of these patients have facet arthropathy,[2] which was likely present before surgery. As pointed out by Wilkinson,[8] degenerated disk collapses, causes misalignment of the facet joint, which can result in facet pain. Diagnostic facet medial branch injections may help to determine who may benefit from radiofrequency rhizotomy.[5–7] Discectomy may lead to a further collapse of the disk and cause foraminal stenosis and secondary nerve root compression.[6] The other flaw in the terms is the anatomical inaccuracy. There are other varieties of spine surgery than laminectomy. These include discectomy, anterior interbody fusion, posterior interbody fusion, pedicle screw, and other forms of arthrodesis. Furthermore, new techniques are constantly evolving. The proposed term of Post-surgical Spine Syndrome encompasses all forms of spinal surgery. It also covers the pathological conditions that existed prior to surgery, as well as conditions that may be related to the surgery, such as nerve root compression or injury, epidural fibrosis, arachnoiditis, adjacent level degeneration, and spinal instability. If accepted, the new descriptions for the existing ICD-9 codes will be as follows: 722.80 Post-surgical spine syndrome, unspecified region 722.81 Post-surgical spine syndrome, cervical region 722.82 Post-surgical spine syndrome, thoracic region 722.83 Post-surgical spine syndrome, lumbar region When ICD-10 officially replaces ICD-9, the code for all PSSS will be M96.1. The incidence of PSSS may be reduced by a meticulous neurological examination and careful patient selection.[3,7,8] The facet and sacroiliac joints should always be examined, particularly when the pain is predominantly in the lower back, or when it radiates only to the thigh or groin and not below the knee. Patients who have mild or no neurological deficits and whose radiographic or electrophysiological studies show minimal nerve root compression may benefit from a diagnostic selective nerve root injection, before making a surgical decision. Finally, referred visceral pain from the pelvic or abdominal organs should also be excluded by a comprehensive examination. Adherence to these simple guidelines can result in a significant reduction in the pain and suffering, as also the enormous financial cost of PSSS.[3]

Percutaneous Lumbar Decompression With SpineJet Hydrosurgery in the Treatment of Lumbar Spinal Stenosis Secondary to Ligamentum Flavum Hypertrophy.

Introduction Lumbar spinal stenosis with symptomatic neurogenic claudication is a frequently encountered clinical entity which requires endoscopic or open spine surgery once the patients fail to respond to conservative therapies. In this case report we present a novel minimally invasive decompression technique using a fluid jet device (HydroCision Inc, Billerica, MA, USA) for a patient with symptomatic spinal stenosis secondary to ligamentum flavum hypertrophy. To our knowledge this approach has never been described in the medical literature. Case Presentation An 85 years old patient presented because of intractable right leg pain with minimal activities. She was diagnosed with significant right foraminal stenosis and she failed conservative non-invasive therapies. Conclusions Percutaneous lumbar hydro decompression can be a promising method for the treatment of the patients with lumbar spinal stenosis and neurogenic claudication secondary to ligamentum flavum hypertrophy.

Managing loss of intrathecal baclofen efficacy: Review of the literature and proposed troubleshooting algorithmAuthors Respond:

We congratulate Boster et al.1 for proposing a troubleshooting algorithm for loss of intrathecal baclofen (ITB) efficacy. The catheter accounts for most of the problems with ITB. We are concerned that the algorithm excludes contrast study, and indium scan, for assessing catheter function. The authors recommend catheter replacement if catheter access port (CAP) aspiration is negative or inconclusive. The result is likely to be some unnecessary surgeries. Vender et al.2(p14) cautioned, “often, a functional catheter will not aspirate CSF. This does not prove that a catheter occlusion exists.” CAP aspiration is …

Role of Indium Scans in Assessing Catheter Malfunction With Implanted Spinal Infusion Pumps

To the Editor, We applaud Michael S. Turner, MD, for his well-written article on the value of spiral computed tomography (CT) in the assessment of various syndromes of catheter malfunction with the SynchroMed infusion systems (Medtronic, Minneapolis, MN) [1]. His proposed algorithm for troubleshooting s useful for practitioners who manage implanted spinal nfusion pumps. This letter concerns the author’s comments about the role f the indium scan. Our experience with an indium scan tudy of the pump differs from that of the author, and we ould like to dispel any suggestion that this useful tool hould be abandoned. Differences in techniques may explain he variance in outcomes. In the hands of a clinician who is experienced with filling he pump, injecting a small volume of indium into the eservoir is not technically difficult; on the contrary, the eservoir is easier to access than the catheter access port CAP). In 23 indium studies in 19 patients, we injected 0.6 Ci of indium 111 diethylenetriaminepentaacetic acid DTPA) into the reservoir. Images were acquired 3 days later y using a dual head gamma camera with parallel collimaor and energy peaks set at 173 and 247 keV with 20% indows [2]. With this technique, the quality of our mages was excellent, and we were able to see activity long the catheter and spinal canal into the cerebral ciserns in patients with patent and normal functioning cathters [2]. Mechanical pump failure, catheter occlusion, nd catheter leak were easily identified. All results correated with subsequent clinical or surgical findings. There ere no false results. We are concerned regarding the author’s recommendaion that the patient should be scheduled for catheter eplacement if 3 mL of cerebrospinal fluid (CSF) cannot be spirated from the CAP. This approach is likely to lead to nnecessary surgery. We have had a number of patients in hom CSF could not be aspirated from the CAP, and ubsequent indium scans showed patent catheter and adioisotope tracer into the cerebral cisterns. All the paients responded to dose adjustment. Recently, a patient ad a rotor stall in the pump, and a catheter study was ttempted to be certain that it was patent. No fluid could e aspirated from the CAP. At pump replacement, there as excellent backflow of CSF from the catheter as soon as t was disconnected from the pump. There was no need to