Condition: Chronic Postoperative Pain · Sponsor: Sahlgrenska University Hospital
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 …
This description comes directly from the study's public registry record.
Kliment Gatzinsky, MD, PhD · +46733407733 · kliment.gatzinsky@neuro.gu.se
Jan Willem Kallewaard, MD, PhD · +31622412029 · jkallewaard@rijnstate.nl
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06585033