• Mark D Bishop and Steven Z George.
• Department of Physical Therapy.
• Clin J Pain. 2023 Mar 1; 39 (3): 119126119-126.

ObjectivesIn preclinical prognostic studies, the description of expected outcomes during an informed consent process indicates that the extent of pain and disability experienced and recovery time is unknown. In intervention studies, the consent process suggests that pain and disability will definitely occur and a treatment provided. Our objective was to determine whether study design (prognosis or intervention) was associated with the severity of pain intensity and disability reports from a preclinical model.Materials And MethodsWe pooled pain and disability outcomes from prognostic and intervention studies using an exercise-induced muscle injury model of pain. Pain intensity, disability, and fear of pain were collected by validated self-report measures. Pain and disability data were z-transformed for pooled analyses and compared across the study design.ResultsData from 310 people were included. The primary findings were that self-reported pain intensity and disability were: (1) higher in prognostic studies than in the intervention studies and (2) associated with fear of pain. A secondary finding was that fear of pain was lower in the intervention compared with the prognostic studies.DiscussionAlthough there are other possible explanations, we speculate that these results could be related to the uncertainty inherent to providing informed consent for a prognostic study. In light of these findings, we recommend that informed consent language be more carefully considered when pain is induced in a controlled manner. Incorporating informed consent language commonly used in prognostic studies could result in higher pain intensity and disability ratings in studies that use preclinical models to test the efficacy of pain interventions.Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.

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