Placebo Effect In Spinal Cord Electrical Stimulation for Pain

Launched by SAHLGRENSKA UNIVERSITY HOSPITAL · Sep 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness of spinal cord stimulation (SCS) in relieving chronic leg pain that some people experience after lumbar spinal surgery, especially when other treatments haven't worked. The study compares the real SCS treatment to a placebo (which is like a fake treatment that doesn’t provide stimulation) to see which one helps reduce pain more over a year. Participants will be people aged 18 to 70 who have had consistent leg pain for at least six months after their surgery and didn’t find relief from other treatments. They should also have shown some improvement during a preliminary test with SCS.

If you join the study, you will receive either the active SCS treatment or the placebo without knowing which one you have, for three months at a time. Throughout the year, the researchers will check how your pain changes, as well as how it affects your daily life, sleep, and use of pain medications. This trial is important because it aims to provide clearer answers about how effective spinal cord stimulation really is for managing pain in this situation.

Gender

ALL

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.