Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol

Al‐Kaisy, Adnan; Royds, Jonathan; Palmisani, Stefano; Pang, David; Wesley, Samuel; Taylor, Rod S; Cook, Andrew; Eldabe, Sam; McCracken, Lance M.; Duarte, Rui; Fairbank, Jeremy

doi:10.1186/s13063-019-3831-4

Cited by 17 publications

(6 citation statements)

References 28 publications

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“…HF-SCS is a recent advancement in neuromodulation. In addition to previously mentioned studies, the similar clinical trials regarding a diabetic neuropathy [18] and a low back pain [19,20] were announced.…”

Section: Discussionmentioning

confidence: 99%

High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial

Kilchukov

Kiselev

Горбатых

et al. 2023

Stereotact Funct Neurosurg

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Introduction: The objective of the study is to determine if high-frequency (1 kHz) spinal cord stimulation (SCS) is better than low-frequency SCS for pain relief in chronic limb-threatening ischemia (CLTI). Methods: HEAL-SCS trial was designed as an open-label, parallel-group, single-center randomized study with a 1:1 allocation ratio. The trial was conducted in Meshalkin National Medical Research Center between August 2018 and February 2020. Total 56 patients underwent screening, 50 were enrolled, 6 were rejected. The participants were randomized into 2 cohorts of 25 patients each by an external coordinator using an online tool. A neurosurgeon and a vascular surgeon both examined all patients and estimated the pain intensity using visual analog scale (VAS), quality of life with short-form-36 health survey (SF-36), and functional status by walking impairment questionnaire (WIQ) at 3 and 12 months. Tissue perfusion was evaluated for 34 patients using transcutaneous oxygen tension measurement (TcPO2) at baseline and in 12 months. Results: All 50 patients (84% men, median age 66.5 y.o) were available for primary outcome assessment 3 and 12 months after implantation. Intention-to-treat analysis demonstrated comparative advantage of HF-SCS over LF-SCS at 3 months with mean VAS score 2.8 (95% CI, 2.4; 3.2) and 3.3 (95% CI, 3.0; 3.6), respectively (p = 0.031). Clinical superiority of HF-SCS persisted at 12-month follow-up (p < 0.001). HF-SCS produced significantly greater pain relief by WIQ at 3 (p < 0.001) and 12 months (p = 0.009). Despite stair-climbing ability was better in HF-SCS group (p = 0.02), no significant difference between groups was found at 1-year post-op in terms of speed (p = 0.92) and distance scores (p = 0.68). Accordingly, the general and mental health domains of SF-36 were significantly better in HF-SCS at 12 months. Despite a tendency toward better resting oxygen pressure in HF-SCS group, there was no intergroup difference by TcPO2 (p = 0.076). Only 1 patient (2%) required above-the-knee amputation at 10 months after LF-SCS implantation. Conclusion: High-frequency SCS provides better pain relief, life quality, and functional performance in patients with CLTI during short-term follow-up. The lack of perfusion difference between high-frequency and conventional SCS requires further examination to the possible long-term advantages of the method.

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Section: Discussionmentioning

confidence: 99%

High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial

Kilchukov

Kiselev

Горбатых

et al. 2023

Stereotact Funct Neurosurg

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“…A study design was published by Al‐Kaisy et al 41 that investigated the use of 10‐kHz SCS compared to sham in a more narrowly defined NSRBP population. Inclusion criteria included predominant back pain, degenerative disc disease, and neuropathic pain indicated by the PainDETECT questionnaire.…”

Section: Discussionmentioning

confidence: 99%

High‐Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial

et al. 2020

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Background Spinal cord stimulation (SCS) has been shown to provide pain relief for chronic back and leg pain due to failed back surgery syndrome. But many patients with chronic back pain have not had major back surgery or are not good candidates for surgery, and conventional medical management (CMM) provides limited relief. We have termed this condition nonsurgical refractory back pain (NSRBP). Level 1 evidence does not yet exist showing the therapeutic benefit of SCS for NSRBP. Objective To compare 10‐kHz SCS plus CMM (10‐kHz SCS + CMM) to CMM alone for treatment of NSRBP in terms of clinical and cost effectiveness. Study Design Multicenter, randomized controlled trial (RCT), with subjects randomized 1:1 to either 10‐kHz SCS + CMM or CMM alone. Optional crossover occurs at 6 months if treatment does not achieve ≥50% pain relief. Methods Patients with NSRBP as defined above may be enrolled if they are ineligible for surgery based on surgical consultation. Subjects randomized to 10‐kHz SCS + CMM will receive a permanent implant if sufficient pain relief is achieved in a temporary trial. Both groups will receive CMM per standard of care and will undergo assessments at baseline and at follow‐ups to 12 months. Self‐report outcomes include pain, disability, sleep, mental health, satisfaction, healthcare utilization, and quality of life. Results Enrollment was initiated on September 10, 2018. Prespecified independent interim analysis at 40% of the enrollment target indicated the sample size was sufficient to show superiority of treatment at the primary endpoint; therefore, enrollment was stopped at 211. Conclusions This large multicenter RCT will provide valuable evidence to guide clinical decisions in NSRBP.

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“…Control groups for medical device trials have included optimal “standard” care, fully implanted inactive devices, and perceptible sham stimulation that is not optimized for the target outcome with varying degrees of potential blinding. Currently, trials of high‐frequency stimulation for pain that is not perceptible to the participant subject are making the design of scES pain studies simpler (54), yet continue to reveal large placebo effects (55). However, this imperceptible stimulation modality is not effective for the SCI endpoints under current evaluation, such as improved motor or autonomic function.…”

Section: Design Challenges For Medical Device Trialsmentioning

confidence: 99%

Clinical Trial Designs for Neuromodulation in Chronic Spinal Cord Injury Using Epidural Stimulation

Boakye

Ugiliweneza

Mesbah

et al. 2021

Neuromodulation: Technology at the Neural Interface

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Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol

Cited by 17 publications

References 28 publications

High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial

High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial

High‐Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial

Clinical Trial Designs for Neuromodulation in Chronic Spinal Cord Injury Using Epidural Stimulation

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