Spinal cord stimulation plus rehabilitation for severe chronic neuropathic leg pain
Optimizing Treatment for Chronic Neuropathic Pain: A Replicated Single Case Experimental Design Evaluating a Treatment Bundle Consisting of Multidisciplinary Rehabilitation and Spinal Cord Stimulation (SCS-R)
This project will try combining spinal cord stimulation with a multidisciplinary rehabilitation program to reduce severe nerve pain and improve physical function in adults with chronic neuropathic leg pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT07403331 on ClinicalTrials.gov |
What this trial studies
This single-case experimental design uses repeated measurements within each participant to compare a pre-implant baseline, a randomized short waiting period after implantation, a 12-week active treatment phase combining spinal cord stimulation (SCS) and multidisciplinary rehabilitation, and a five-week follow-up about six months after implantation. Phase A1 is the baseline, A2 is a randomized 2–4 week waiting period, B is the 12‑week SCS+rehabilitation phase (analyzed as early B1 and later B2), and FU is the follow-up period. Primary contrasts are predefined as A1 vs B1 for leg pain intensity and A1 vs B2 for physical function (PROMIS-29), with repeated within-patient measures allowing phase-to-phase comparisons. Eligible participants are adults 18–60 with dominant peripheral neuropathic pain in one or both legs who have tried prior treatments and can attend the Oslo center and use the SCS device.
Who should consider this trial
Good fit: Ideal candidates are adults 18–60 with chronic (>6 months) peripheral neuropathic pain mainly in one or both legs (post‑spinal pain syndrome or localized nerve damage) who have tried standard treatments, can travel to Oslo, speak Norwegian, and can operate an SCS device.
Not a fit: Patients whose pain is not primarily in the legs, who have widespread non‑neuropathic pain, cannot travel to Oslo, lack Norwegian language skills, have cognitive impairment, exceed opioid limits (>50 mg OMEQ daily), or have ongoing compensation/claims issues may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the combined SCS and multidisciplinary program could meaningfully reduce leg neuropathic pain and improve daily physical function and coping.
How similar studies have performed: Previous studies indicate SCS can relieve post‑surgical or injury‑related neuropathic leg pain and multidisciplinary care helps long‑term pain, but combining SCS with a multidisciplinary rehabilitation bundle has not been published.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Peripheral neuropathic pain in one or both legs for \>6 months due to: * (1) Post Spinal Pain Syndrome (type 1 or 2). * (2) Localized nerve damage. * The area of the neuropathic pain in the leg(s) must be the dominant pain component. * Age ranges from 18-60 years. * Previous standard conservative (or surgical) treatment attempted. * Opioid use within permissible limits at implantation time (daily opioid dose \<50 mg OMEQ). * Willingness to actively participate in the treatment bundle. * Living within reasonable travelling distance from Oslo. * Proficiency in understanding oral and written Norwegian, essential to benefit from the program that relies on mutual comprehension, nuanced conversation, and emotional expression, which are language-dependent. * Cognitive capacity to provide informed consent. * Ability to master the technical aspects of the SCS system (switching programs on the remote control). Exclusion criteria: * Currently undergoing the claims process for health benefits (e.g., disability pensions from NAV (Norwegian Labour and Welfare Administration). * Presenting a psychological or psychiatric disorder that may impact treatment efficacy. * Chronic generalized pain conditions. * Other pain conditions in the affected area, such as osteoarthritis. * Pregnancy.
Where this trial is running
Oslo
- Department of pain management and research, Oslo university hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Lars-Petter Granan, Ph.D — Department of pain management and research, Oslo university hospital
- Study coordinator: Christopher Ekholdt, PhD-student
- Email: chrekh@ous-hf.no
- Phone: +4723026161
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.