Placebo Effect In Spinal Cord Electrical Stimulation for Pain

Recruiting now · Not applicable

Conditions studied: Chronic Postoperative Pain

In brief

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.

Key facts

Study ID: NCT06585033
Run by: Sahlgrenska University Hospital
People needed: 50
Starts: 2024-11-15
Expected to finish: 2027-06-30
Last updated by the study team: 2025-12-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 \&amp;lt;1 year.
Ongoing local infection or other skin disease where the IPG is planned to be placed.
Pregnancy.

Where it is running

Department of Anaesthesiology and Pain Management, Rijnstate Hospital — Arnhem, Netherlands (enrolling)
Department of Neurosurgery, Stavanger University hospital — Stavanger, Norway (enrolling)
Department of Neurosurgery, Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
Department of Anesthesiology and Intensive Care/Pain Center, Sahlgrenska University Hospital Östra — Gothenburg, Sweden (enrolling)

Full record on ClinicalTrials.gov

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