Evaluating the effectiveness of spinal cord stimulation for chronic pain relief
Spinal Cord Stimulation for the Treatment of Therapy-Resistant Neuropathic Pain After Lumbar Spinal Surgery - A Randomized, Double-Blind, Sham-Controlled, Cross-over Study
NA · Sahlgrenska University Hospital · NCT06585033
This study is testing if spinal cord stimulation can help people with chronic leg pain after back surgery feel better compared to a placebo treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital (other) |
| Locations | 4 sites (Arnhem and 3 other locations) |
| Trial ID | NCT06585033 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether spinal cord stimulation (SCS) is more effective than a placebo in reducing chronic postoperative neuropathic leg pain in patients who have undergone lumbar spinal surgery. The study employs a multicenter, double-blind, randomized, sham-controlled design, where participants will receive either active or subthreshold stimulation over a 12-month period. The primary outcome will be assessed through changes in leg pain intensity scores, alongside secondary measures including quality of life and medication use. Participants must demonstrate adequate pain relief during a preliminary test trial to qualify for the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with chronic neuropathic leg pain following lumbar spinal surgery who have not responded to conservative treatments.
Not a fit: Patients with active implantable devices or those unable to operate the SCS device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from chronic postoperative pain.
How similar studies have performed: Previous randomized controlled trials have shown significant long-term pain reduction with spinal cord stimulation, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History consistent with PSPS2 of at least 6 months after the last spinal surgery. The patient experienced no effect of conservative treatments and has been assessed as not eligible for further spinal surgery. * Patients between 18-70 years of age. * Average perceived pain intensity in one or both legs of 5 or more and average perceived pain intensity in the back of less than 3 measured with the validated 11-box NRS (0 no pain, 10 worst imaginable pain) * The patient should have been informed verbally and in writing about the study and should have provided informed written consent to participate. * Adequate pain relief effect (50% or more) after a two week trial with active test stimulation. Exclusion Criteria: * Subject is unable to understand or operate the SCS device. * Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system. * Ongoing coagulation disorder. * Ongoing abuse of alcohol, drugs, or prescription opioids. * Active debilitating psychiatric illness. * Active malignancy. * Condition with increased general infection sensitivity, such as known immunodeficiency. * Expected lifespan \<1 year. * Ongoing local infection or other skin disease where the IPG is planned to be placed. * Pregnancy.
Where this trial is running
Arnhem and 3 other locations
- Department of Anaesthesiology and Pain Management, Rijnstate Hospital — Arnhem, Netherlands (RECRUITING)
- Department of Neurosurgery, Stavanger University hospital — Stavanger, Norway (RECRUITING)
- Department of Neurosurgery, Sahlgrenska University Hospital — Gothenburg, Sweden (RECRUITING)
- Department of Anesthesiology and Intensive Care/Pain Center, Sahlgrenska University Hospital Östra — Gothenburg, Sweden (RECRUITING)
Study contacts
- Principal investigator: Kliment Gatzinsky, MD, PhD — Department of Neurosurgery, Sahlgrenska University Hospital
- Study coordinator: Kliment Gatzinsky, MD, PhD
- Email: kliment.gatzinsky@neuro.gu.se
- Phone: +46733407733
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.
Conditions: Chronic Postoperative Pain, Spinal cord stimulation, Lumbar spine surgery, Chronic pain, Pain reduction, Placebo, Randomized controlled trial