Actively Recruiting
Does Spinal Cord Stimulation (SCS) Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
Led by University of Aarhus · Updated on 2026-01-09
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Does Spinal Cord Stimulation Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with an implanted spinal cord stimulation device for chronic pain
- Patients able to consent and cooperate in the study
- Use of continuous paresthesia-free spinal cord stimulation for at least 6 months before joining
- Pain score of 7 or less on a 0-10 scale in the most painful treated area upon inclusion
- Patients not receiving other neuromodulation treatments
- No changes in pain-related medication during the last 30 days (pro necessitate medication allowed)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Four test sessions with at least one week between each session
Participants receive spinal cord stimulation device settings with different combinations of stimulation turned on or off and verbal suggestions about the stimulation status.
4 visits (in-person), each session at least one week apart
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
C
Christina Emborg, Postdoc
L
Lene Vase, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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