NCT06585033 Placebo Effect In Spinal Cord Electrical Stimulation for Pain
| NCT ID | NCT06585033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Chronic Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-11-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 \<1 year. * Ongoing local infection or other skin disease where the IPG is planned to be placed. * Pregnancy.
Contact & Investigator
Kliment Gatzinsky, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Neurosurgery, Sahlgrenska University Hospital
Frequently Asked Questions
Who can join the NCT06585033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Chronic Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06585033 currently recruiting?
Yes, NCT06585033 is actively recruiting participants. Contact the research team at kliment.gatzinsky@neuro.gu.se for enrollment information.
Where is the NCT06585033 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Stavanger, Norway, Gothenburg, Sweden, Gothenburg, Sweden.
Who is sponsoring the NCT06585033 clinical trial?
NCT06585033 is sponsored by Sahlgrenska University Hospital. The principal investigator is Kliment Gatzinsky, MD, PhD at Department of Neurosurgery, Sahlgrenska University Hospital. The trial plans to enroll 50 participants.