Placebo Effect In Spinal Cord Electrical Stimulation for Pain
Condition(s) studied
Investigational drug(s) / intervention(s)
Spinal cord stimulation: Stimulation off
Spinal cord stimulation: Stimulation on
Study summary
Objective: To evaluate if spinal cord stimulation (SCS) performs better than placebo (no stimulation) in the long term to reduce persistent neuropathic leg pain refractory to medication and other conservative treatments in patients who have undergone lumbar spinal surgery.
Study design: Multicenter, double blind, randomized, sham-controlled trial.
After a positive SCS test trial, participants (18-70 years) will be implanted with a non-rechargeable SCS system providing active, subthreshold stimulation and followed for 12 months in a blinded cross-over design. The primary outcome measure is the difference in change in leg pain intensity scores using the Numeric Rating Scale (NRS) between a 3-month period with optimized subthreshold stimulation, and a 3-month period with no stimulation, as compared to baseline. Quality of life, physical functioning, sleep quality, return to work, and reduction in medication use will also be investigated.
Background: Up to 20% of patients who have undergone lumbar spinal surgery experience persistent back/leg pain leading to long-term reduction in functionality and quality of life. SCS is an established and safe, minimally invasive treatment for these patients when no further surgery is indicated and conservative therapies have been found to be ineffective. Placebo-controlled studies, comparing active and sham stimulation, were lacking until recently as traditional SCS relied on the patient feeling the stimulation (paresthesia). Technological progress with development of paresthesia-free stimulation forms now allows for the execution of placebo-controlled studies. A recent trial showing no significant difference in long-term effectiveness between active SCS and sham suffers from significant methodological shortcomings. This necessitates further sham-controlled studies to determine the effectiveness of SCS.
Eligibility
Primary outcome measure(s)
- Comparison between active subthreshold spinal cord stimulation and sham stimulation in reducing neuropathic leg pain — Baseline and 3+3 months
The difference in change in neuropathic leg pain intensity scores measured by the numeric rating scale (NRS) questionnaire using a 0-10 scale between a 3-month period with subthreshold stimulation and a 3-month period with sham stimulation, as compared to baseline. Zero means no pain and 10 means the worst pain imaginable with higher scores indicating worse outcome.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Sahlgrenska University Hospital trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06585033 on ClinicalTrials.gov ↗ ← All trials in the Netherlands