Abstract
In 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. We 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. Data 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. Although 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.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.