Does spinal cord stimulation provide relief beyond patients' expectations?
Does Spinal Cord Stimulation (SCS) Have an Effect Beyond Patients' Expectations? An Investigation of Treatment and Placebo Effects
This study will test whether turning spinal cord stimulation on or off changes pain beyond what adults with implanted SCS devices expect.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT07330466 on ClinicalTrials.gov |
What this trial studies
Adults who already have implanted paresthesia-free spinal cord stimulation (SCS) devices will attend four blinded test sessions of 4–5 hours each. On each session investigators will record baseline pain, then change the SCS state (on or off) while patients are told either that it is on or off, and patients will rate pain immediately and every 15 minutes. The design compares real stimulation effects with expectation/placebo effects within the same person. Participants may continue their usual treatment at any time and must have had stable SCS use and stable pain medications prior to enrollment.
Who should consider this trial
Good fit: Adults over 18 with a continuous paresthesia-free SCS implanted for at least six months to treat chronic pain, stable pain medications for 30 days, a pain score of 7 or less in the treated area, and willingness to attend four test sessions are ideal candidates.
Not a fit: People without an implanted SCS, those using other neuromodulation treatments, or those with recent changes to pain medications are unlikely to meet criteria or benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians distinguish true SCS effects from expectation effects and improve how SCS is programmed and explained to patients.
How similar studies have performed: Prior research has shown that patient expectation can alter pain reports and that placebo-like effects occur with neuromodulation, but the specific blinded on/off/told design used here is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients (\>18 years of age) with SCS implanted to treat chronic pain. * Patients who consent to participation and can cooperate in the study. * Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study. * Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion. * Patients not receiving other neuromodulation treatment. * Patients who have not undergone changes in their (pain relevant) medication during the last 30 days (pro necessitate medication allowed).
Where this trial is running
Aarhus N
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Christina Emborg, Postdoc
- Email: chrisemb@psy.au.dk
- Phone: +4520910215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.