Evaluating Treatment and Placebo Effects of Spinal Cord Stimulation for Chronic Pain in Adults

What this Trial Is About

This research aims to evaluate the treatment outcomes of Spinal Cord Stimulation SCS in patients with chronic pain who have had an SCS device implanted. The study investigates both the actual effect of the stimulation and the placebo effect by varying patients knowledge and the status of their stimulation. The purpose is to understand how much of the pain relief is due to the stimulation itself versus patients expectations, with participants blinded to the treatment conditions throughout the study. Participants will attend four test sessions, each lasting 4 to 5 hours, spaced at least one week apart. During these sessions, patients will have their SCS turned on or off, and they will be told either that the stimulation is on or off, sometimes correctly and sometimes incorrectly. This results in four different conditions being tested. Patients maintain their usual treatment at all times. The study uses a randomized, quadruple-blind design to compare these conditions. Throughout the study, patients will report their subjective pain intensity using a 0-10 Mechanical Visual Analogue Scale M-VAS at baseline and repeatedly every 15 minutes during the test sessions. Researchers will closely monitor these pain ratings to assess the effects of stimulation and expectation. Participation involves attending all four sessions, and the primary outcome is the change in pain intensity during these sessions. The study is sponsored by the University of Aarhus and will continue until July 2027.

Does Spinal Cord Stimulation Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects