At a glance
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Brain Mechanisms For Clinical Placebo in Chronic Pain: A Randomized Clinical Trial of Placebo, Active Treatment, and No Treatment in Chronic Back Pain
In Brief
A Phase 4 clinical trial evaluating Naproxen, Omeprazole, and 1 other intervention for Chronic Low Back Pain. Completed, enrolled 94 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening.
Subjects enrolled in the active treatment arm will receive 20mg of Omeprazole prescribed twice daily, once in the morning and evening. Furthermore, subjects should take this one hour before a meal.
Subjects enrolled in the inactive treatment arm will receive two prescriptions, however, there are no active ingredients and are intended to look identical to the active treatment. Therefore, subjects will be instructed exactly the same way as if they were ingesting the active treatment.