Would Training Aimed to Improve Pain Reporting Accuracy Affect the Placebo Response?

Purpose: To examine whether the participants training to improve their pain reporting accuracy would affect the results of a Randomized Controlled Trial (RCT).

Methods:

A hundred healthy subjects will be recruited for a cross-sectional, double-blind, randomized experiment. The trial consists of 6 sessions, including data collection, pain sensitivity tests, FAST and EPT training, and finally an ibuprofen or placebo medication and a series of pain sensitivity tests using experimental pain assessment models.

This study emphasizes the ability of the individual to report painfully and examines intervention designed to improve this ability.

Research hypotheses: (1) Greater ability of participants to be accurate in the FAST test will be associated with a lower response to placebo; (2) Training of participants will improve the accuracy of pain reports in response to experimental stimulation.

Research Tool: To measure the ability to be accurate in pain reports and the response to placebo and drug, we will use two devices designed to produce two types of pain, pain due to thermal stimulation and pain in response to mechanical stimulation.

1. The Thermal Sensory Analyzer II is a precise and computerized device capable of producing and recording a response to thermal stimuli and extremely strong vibrations such as heat, cold and vibrations.
2. The AlgoMed-Medoc device is a device that allows the creation of local pressure on the selected area on the body (Over thenar eminence).

Procedure: The subjects are recruited for the experiment after making a telephone call, performing a test of conformity and setting a date for the first meeting. After receiving their written consent, the participants will complete a personal and demographic information questionnaire and undergo a series of sensitivity tests. During the training phase, pain intensity scores of each stimulus will be recorded using the Numerical Rating Scale (NRS). The last stage includes two sessions in which subjects will receive a real drug once (ibuprofen) and a placebo once. And at the end they will again examine pain thresholds and mechanical and thermal stimulation tests on the ends. Each participant will receive monetary compensation for his participation and according to the stage at which he is found as detailed in the trial protocol.

Results: not complete.

Conclusion: not complete.