Adnan Al-Kaisy

High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study.

The objective of this prospective, open‐label, multicenter European clinical trial was to quantify the efficacy and safety of a spinal cord stimulation (SCS) system that utilizes high‐frequency (up to 10 kHz) waveforms, which do not produce paresthesia, for the treatment of chronic, intractable pain of the back and/or limbs.

Emerging treatment for chronic migraine and refractory chronic migraine

Introduction: Chronic migraine (CM), the suffering of 15 or more headache days with at least 8 of these migraine days, afflicts 1.3% - 5.1% of the global population. CM is the most common disorder faced by experts in tertiary headache centers. When resistant to conventional medical treatment and prophylactic medication this condition is known as refractory chronic migraine (RCM). RCM is one of the greatest challenges in headache medicine. Areas covered: State-of-the-art and future medical treatments of chronic migraine include: OnabotulinumtoxinA, antiepileptic drugs (Levetiracetam, Magnesium valproate hydrate, Lacosamide, BGG-492), 5-HT agonists (Lasmiditan, NXN-188, novel delivery systems of Sumatriptan, a well-established drug treatment for acute migraine), CGRP receptor antagonists (BMS-927711), ML-1 agonists (Ramelteon), orexin receptor antagonist (MK-6096), plant-derived compound (LLL-2011) and other multitarget drugs such as Tezampanel, Tonabersat, intranasal carbon dioxide and BOL-148. The role for neuromodulation, the application of targeted electrical stimulation, will be examined. Expert opinion: Medication overuse headache (MOH) is now recognized to be a major factor in many cases of both chronic and refractory chronic migraine. MOH must be addressed prior to evaluating the effectiveness of new preventative and prophylactic treatment approaches. Innovative new drugs and electrical neuromodulation are promising CM treatments. Future studies must carefully screen patients and acquire data that can lead to personalized, tailored treatment strategies.

A six year retrospective review of occipital nerve stimulation practice - controversies and challenges of an emerging technique for treating refractory headache syndromes

BackgroundA retrospective review of patients treated with Occipital Nerve Stimulation (ONS) at two large tertiary referral centres has been audited in order to optimise future treatment pathways.MethodsPatient’s medical records were retrospectively reviewed, and each patient was contacted by a trained headache expert to confirm clinical diagnosis and system efficacy. Results were compared to reported outcomes in current literature on ONS for primary headaches.ResultsTwenty-five patients underwent a trial of ONS between January 2007 and December 2012, and 23 patients went on to have permanent implantation of ONS. All 23 patients reached one-year follow/up, and 14 of them (61%) exceeded two years of follow-up. Seventeen of the 23 had refractory chronic migraine (rCM), and 3 refractory occipital neuralgia (ON). 11 of the 19 rCM patients had been referred with an incorrect headache diagnosis. Nine of the rCM patients (53%) reported 50% or more reduction in headache pain intensity and or frequency at long term follow-up (11–77 months). All 3 ON patients reported more than 50% reduction in pain intensity and/or frequency at 28–31 months. Ten (43%) subjects underwent surgical revision after an average of 11 ± 7 months from permanent implantation - in 90% of cases due to lead problems. Seven patients attended a specifically designed, multi-disciplinary, two-week pre-implant programme and showed improved scores across all measured psychological and functional parameters independent of response to subsequent ONS.ConclusionsOur retrospective review: 1) confirms the long-term ONS success rate in refractory chronic headaches, consistent with previously published studies; 2) suggests that some headaches types may respond better to ONS than others (ON vs CM); 3) calls into question the role of trial stimulation in ONS; 4) confirms the high rate of complications related to the equipment not originally designed for ONS; 5) emphasises the need for specialist multidisciplinary care in these patients.

The Use of 10‐Kilohertz Spinal Cord Stimulation in a Cohort of Patients With Chronic Neuropathic Limb Pain Refractory to Medical Management

It is the purpose of this study to document our experience with the use of a 10‐kHz high‐frequency spinal cord stimulation (SCS) device for the relief of neuropathic pain of the upper and lower limbs.

Subcutaneous Target Stimulation–Peripheral Subcutaneous Field Stimulation in the Treatment of Refractory Angina: Preliminary Case Reports

Abstract:  Spinal cord stimulation is now established as an effective treatment for refractory angina. We present the use of an alternative approach to neuromodulation of anginal pain using subcutaneous leads placed at the site of pain. In this case series, five patients with refractory angina received successful treatment with subcutaneous target stimulation–peripheral subcutaneous field stimulation. This technique was able to provide good analgesia in two patients that had had poor pain relief from existing spinal cord stimulators. All five patients achieved significant pain relief with a reduction in symptoms and a decrease in the use of pain medication.

10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study.

To explore the effectiveness of 10 kHz high frequency spinal cord stimulation (HF10 therapy) treatment of chronic low back pain in patients who have not had spinal surgery.

Long-Term Improvements in Chronic Axial Low Back Pain Patients Without Previous Spinal Surgery: A Cohort Analysis of 10-kHz High-Frequency Spinal Cord Stimulation over 36 Months

Objective This prospective, open-label study was designed to evaluate the long-term effectiveness of 10-kHz high-frequency spinal cord stimulation (SCS) in the treatment of chronic axial low back pain with no history of spinal surgery. Methods Patients with chronic low back pain without previous spinal surgery underwent assessment by a multidisciplinary pain and surgical team to confirm eligibility. After a successful temporary trial of 10-kHz HF-SCS therapy, defined by ≥50% back pain reduction, enrolled subjects underwent permanent system implantation and were followed up for 36 months. Outcome measures consisted of a 100-mm visual analog scale (VAS) for pain intensity, the Oswestry Disability Index (ODI), and a standard measure of health-related quality of life. Results Twenty-one patients satisfied the inclusion/exclusion criteria. Following a temporary trial, 20 of 21 (95%) subjects were implanted with a pulse generator, and 17 of 20 reached the 36-month time point. From baseline to 36 months, the average VAS pain intensity decreased from 79 ± 12 mm to 10 ± 12 mm, the average ODI score decreased from 53 ± 13 to 19.8 ± 13, and use of opioids decreased from 18 subjects to two subjects. One subject was deceased, unrelated to the study, one subject was explanted due to loss of effectiveness, and one subject was lost to follow-up. Conclusions These results suggest that 10-kHz high-frequency SCS may provide significant, long-term back pain relief, improvement in disability and quality of life, and reduction in opioids for nonsurgical refractory back pain.

EHMTI-0322. Effect of cervical epidural 10khz spinal cord stimulation on patients suffering from chronic, medically-refractory migraine

A significant minority of chronic migraine (CM) patients do not respond to conventional medical treatment. Occipital nerve stimulation is a therapeutic option for refractory CM (rCM). However, randomized studies have failed to demonstrate efficacy. Cervical 10kHz spinal cord stimulation (10kHz-SCS) may provide a superior alternative to occipital stimulation. We report the preliminary results of a prospective, open-label, feasibility study to assess safety and tolerability cervical 10kHz-SCS in rCM patients. The study had EC approval and the subjects gave informed consent. Included subjects were diagnosed with CM by an experienced headache specialist according to IHS guidelines, were refractory to medical treatments as defined by the Refractory Headache Special Interest Section of the AHS, and had failed Botox treatment. Medication Overuse headache was not excluded. Patients underwent a 10kHz SCS-trial followed by a permanent implant if a significant reduction in headache intensity/episodes was reported during the trial. One or two epidural leads were used to cover the C2-C4. At 6 months 7 out of 14 patients reported >30% reduction in headache days. The average headache days reduction from baseline was 6.9±7.3 days (p=0.04), while the reduction in the responder group was 12.9±5.3 days (p=0.001) . Three patients developed IPG tenderness and one had a lead migration that required surgical revision. Paresthesia-free cervical 10kHz-SCS may be an effective therapeutic option for chronic migraineurs refractory to conventional medications and Botox treatment. No conflict of interest.

Sacral Nerve Root Stimulation for Bladder Pain Syndrome/Interstitial Cystitis

Abstract Bladder pain syndrome/interstitial cystitis (BPS/IC) is a severely debilitating, chronic disorder characterized by pain perceived to arise from the bladder, exacerbated by bladder filling, and associated with urinary urgency or frequency. It is a diagnosis of exclusion that can only be made after other pathologies of the bladder, urethra, and other pelvic organs has been ruled out. Optimal management of the disorder should involve a multidisciplinary approach consisting of urologists, gynecologists, colorectal surgeons, pain specialists, dieticians, physiotherapists, and psychologists. Treatments should follow a step-wise approach, starting with the most conservative. Sacral nerve stimulation (SNS) of the bladder and pelvic innervation has been considered a viable option by a number of urologists for the treatment of various voiding disorders, including painful bladder syndrome. In this chapter, we describe the rational of the use of SNS and different techniques currently available to manage the painful bladder syndrome.

Prospective, Randomized, Sham-Control, Double Blind, Crossover Trial of Subthreshold Spinal Cord Stimulation at Various Kilohertz Frequencies in Subjects Suffering From Failed Back Surgery Syndrome (SCS Frequency Study): CROSSOVER TRIAL OF SCS At VARIOUS kHz FREQUENCIES IN FBSS

The increasing use of high frequency paresthesia‐free spinal cord stimulation has been associated with improved outcomes in the therapy of neuropathic pain. What is unknown is the effect of varying frequency on pain relief and the placebo effect.