Healthy Clinical Trial
Official title:
Can Training Increase Reporting Accuracy and Study Power in Human Pain Trials
In previous studies, results of both the Focused Analgesia Selection Test (FAST) procedure, a method to assess pain-reporting accuracy, and the Evoked Pain Training (EPT) procedure, aimed to improve pain-reporting accuracy, correlated with the placebo response. The objectives of the current project were to determine if EPT (1) increases pain reporting accuracy and (2) affect the placebo response in experimental pain study.
Analgesic trials suffer from low assay-sensitivity, and experts in the field are concerned
that many previous negative analgesic trails might be regarded as failed trails. Major
contributor to this concern is the large placebo response observed in analgesic clinical
trials. Recent findings from the investigators group suggest that improving pain reporting
accuracy could increase analgesic trials assay sensitivity by reducing the placebo response.
In previous studies, the investigators developed the Focused Analgesia Selection Test (FAST),
a method to assess pain reporting accuracy. Later on, the investigators developed the Evoked
Pain Training (EPT), aimed to improve pain reporting accuracy. Both these methods constitute
the core of this project. The objectives of the current project are to determine if subject
training increases (1) pain reporting accuracy and (2) the power of an analgesic trial.
Summary of main methods This project objectives will be achieved by preforming a two-stage
study. First, all subjects undergo baseline assessments, including assessment of pain
reporting accuracy (the FAST procedure) (visit #1). Then, subjects enter the first study
stage (training stage), in which half of study subjects (n=50) undergo training to improve
pain reporting accuracy. The training comprise of three in-clinic visits (visits #2, 3, 4) in
which subjects receive feedback on accuracy of pain reports in response to noxious stimuli of
various intensities (the EPT procedure). The EPT is based on repeated application of the FAST
procedure, while providing feedback to subjects in between applications. The other half of
subjects (n=50) undergo a "shame-training". After completion of the training phase, all
subjects enter an experimental cross-over study design (second study phase) comprised of two
in-clinic visits (visits 5 and 6). In each of these two visits, subjects undergo a battery of
experimental pain tests (pre-treatment assessment), take one of two pills (either Ibuprofen
400 mg or identical sugar pill) in a random order, wait approximately 1 hour, and then
undergo the same pain tests again (post-treatment assessment).
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