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BRAIN MECHANISMS FOR CLINICAL PLACEBO IN CHRONIC PAIN: A Partially-Blind Randomized Clinical Trial of Placebo and Chronic Back Pain
This study is designed to examine brain properties for placebo response in chronic back pain patients. The investigators have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can be subdivided into placebo responders and non-responders, and these differences are PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical utility and that its properties can be studied by human brain imaging techniques. In Phase I of the study, the investigators seek to identify brain imaging parameters that predict the propensity for the placebo response in an independent CBP cohort. In Phase II, the investigators will evaluate the interaction between placebo response and medication treatment in individuals stratified as placebo responders versus non-responders. This research is designed to critically assess the neurobiology of placebo analgesia for chronic pain in a partially-blind clinical trial.
Details
| Lead sponsor | Northwestern University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 82 |
| Start date | 2014-10 |
| Completion | 2016-05 |
Conditions
- Chronic Low Back Pain
Interventions
- Naproxen
- Placebo
- Omeprazole
Primary outcomes
- Change in Pain Assessed by Visual Analogue Scale (VAS) — 6 weeks
The primary outcome was changes (% change) in self-reported pain levels using VAS - from 0 (no pain) to 10 (worst imaginable pain). Results are presented as largest percentage (%) change in pain before and after the interventions (baseline and post-intervention, 6 weeks). Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.
Countries
United States