Burst spinal cord stimulation for chronic back pain relief
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: a Randomized Double-blind Sham-controlled Crossover Trial
This study tests if a new type of spinal cord stimulation can help people with chronic back pain after surgery feel better without the uncomfortable tingling that comes with traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT05372822 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of burst spinal cord stimulation (SCS) in treating chronic radicular pain following lumbar spine surgery. Unlike traditional SCS, which relies on paresthesia to mask pain, burst SCS employs high-frequency stimuli to provide pain relief without the uncomfortable tingling sensation. Participants will undergo a two-week testing period to assess the efficacy of the treatment compared to a sham stimulation. The study aims to provide solid evidence for the use of SCS in managing postoperative back pain.
Who should consider this trial
Good fit: Ideal candidates are individuals who have undergone back surgery and experience chronic radicular pain that has not responded to non-surgical treatments for at least six months.
Not a fit: Patients with coexisting conditions that increase procedural risks or specific surgical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management for patients suffering from chronic back pain without the unpleasant side effects of traditional stimulation.
How similar studies have performed: While traditional spinal cord stimulation has been widely used, the burst SCS approach is relatively novel and has not been extensively tested in placebo-controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months * Minimum pain intensity of 5/10 on the leg pain NRS at baseline * Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period * Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital * Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period Exclusion Criteria: * Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy) * History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed. * Abnormal pain behavior and/or unresolved psychiatric illness. * Unresolved issues of secondary gain or inappropriate medication use.
Where this trial is running
Trondheim
- St Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Sasha Gulati, md prof — St. Olavs Hospital
- Study coordinator: Sasha Gulati, md prof
- Email: sasha.gulati@ntnu.no
- Phone: +47 73592020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.