Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial
Summary
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.
Timeline
- Start
- 2014-10
- Primary completion
- 2016-05
- Completion
- 2016-05
Publications
- Branco P, Berger S, Abdullah T, Vachon-Presseau E, Cecchi G, Apkarian AV. Predicting placebo analgesia in patients with chronic pain using natural language processing: a preliminary validation study. Pain. 2023 May 1;164(5):1078-1086. doi: 10.1097/j.pain.0000000000002808. Epub 2022 Oct 18.
- Vachon-Presseau E, Abdullah TB, Berger SE, Huang L, Griffith JW, Schnitzer TJ, Apkarian AV. Validating a biosignature-predicting placebo pill response in chronic pain in the settings of a randomized controlled trial. Pain. 2022 May 1;163(5):910-922. doi: 10.1097/j.pain.0000000000002450.
- Berger SE, Branco P, Vachon-Presseau E, Abdullah TB, Cecchi G, Apkarian AV. Quantitative language features identify placebo responders in chronic back pain. Pain. 2021 Jun 1;162(6):1692-1704. doi: 10.1097/j.pain.0000000000002175.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naproxen | Small molecule | 500 mg | — |
| Comparator | Omeprazole | Other / unclassified | 20 mg | — |