BridgeMD
New treatment option for Chronic Postoperative Pain
Official title Placebo Effect In Spinal Cord Electrical Stimulation for Pain
ClinicalTrials.gov ID: NCT06585033
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- History consistent with PSPS2 of at least 6 months after the last spinal surgery. The patient experienced no effect of conservative treatments and...
- 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...
- 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 likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Arnhem, Netherlands
- Stavanger, Norway
- Gothenburg, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arnhem, Netherlands; Stavanger, Norway; Gothenburg, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.