Journal Article

Accurate pain reporting training diminishes the placebo response: Results from a randomised, double-blind, crossover trial

Kruger, Grant H., Lawal, Oluwadolapo D., Khurana, Nevil, Shecter, Jonathan D., Bothmer, John, Field, Mark, Harte, Steven E., Treister, Roi, Katz, Nathaniel P.

2018

Overview

Analgesic trials frequently fail to demonstrate efficacy of drugs known to be efficacious. Poor pain reporting accuracy is a possible source for this low essay-sensitivity. We report the effects of Accurate-Pain-Reporting-Training (APRT) on the placebo response in a trial of Pregabalin for painful-diabetic-neuropathy. The study was a two-stage randomized, double-blind trial: In Stage-1 (Training) subjects were randomized to APRT or No-Training. The APRT participants received feedback on the accuracy of their pain reports in response to mechanical stimuli, measured by R-square score. In Stage-2 (Evaluation) all subjects entered a placebo-controlled, cross-over trial. Primary (24-h average pain intensity) and secondary (current, 24-h worst, and 24-h walking pain intensity) outcome measures were reported. Fifty-one participants completed the study. APRT patients (n = 28) demonstrated significant (p = 0.036) increases in R-square scores. The APRT group demonstrated significantly (p = 0.018) lower placebo response (0.29 ± 1.21 vs. 1.48 ± 2.21, mean difference ± SD = -1.19±1.73). No relationships were found between the R-square scores and changes in pain intensity in the treatment arm. In summary, our training successfully increased pain reporting accuracy and resulted in a diminished placebo response. Theoretical and practical implications are discussed.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Accuracy / Analgesics / Analysis / Anesthesiology / Arthritis / Biology and Life Sciences / Cardiovascular disease / Clinical trials / Cross-Over Studies / Diabetes / Diabetes mellitus / Diabetic neuropathies / Diabetic neuropathy / Documentation - standards / Dosage and administration / Double-Blind Method / Double-blind studies / Education - standards / Female / Humans / Male / Mechanical stimuli / Medicine and Health Sciences / Meta-analysis / Middle Aged / Neurology / Neuropathy / Pain / Pain - physiopathology / Pain Management / Pain Measurement / Patient Reported Outcome Measures / Physical Sciences / Placebo effect / Pregabalin / Pregnancy / Randomization / Reporting / Research and Analysis Methods / Self Report - standards / Surveys and Questionnaires / Training