Spinal cord stimulation plus rehabilitation for severe chronic neuropathic leg pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.