Status:
RECRUITING
Placebo Effect In Spinal Cord Electrical Stimulation for Pain
Lead Sponsor:
Sahlgrenska University Hospital
Collaborating Sponsors:
Rijnstate Hospital
Conditions:
Chronic Postoperative Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
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 cons...
Detailed Description
1. INTRODUCTION AND RATIONALE SCS is an established and safe, minimally invasive treatment for patients with therapy-resistant chronic neuropathic pain. The treatment is based on the development o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06585033
Start Date
November 15 2024
End Date
June 30 2027
Last Update
December 2 2025
Active Locations (4)
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1
Department of Anaesthesiology and Pain Management, Rijnstate Hospital
Arnhem, Netherlands, 6800
2
Department of Neurosurgery, Stavanger University hospital
Stavanger, Norway, 4019
3
Department of Neurosurgery, Sahlgrenska University Hospital
Gothenburg, Sweden, 41257
4
Department of Anesthesiology and Intensive Care/Pain Center, Sahlgrenska University Hospital Östra
Gothenburg, Sweden, 41650