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โ† Trials
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Placebo Effect In Spinal Cord Electrical Stimulation for Pain

RecruitingNAAges 18 Years - 70 YearsAllSahlgrenska University Hospital
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In plain words

What the trial is, and whether it could suit you

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 redu

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Spinal cord stimulation
  • Spinal cord stimulation
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Where

4 sites
Department of Anaesthesiology and Pain Management, Rijnstate Hospital
Arnhem, Netherlands
Department of Neurosurgery, Stavanger University hospital
Stavanger, Norway
Department of Neurosurgery, Sahlgrenska University Hospital
Gothenburg, Sweden
Department of Anesthesiology and Intensive Care/Pain Center, Sahlgrenska University Hospital ร–stra
Gothenburg, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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