Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

Abstract

There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.

Chronic pain after spinal cord injury: What characteristics make some pains more disturbing than others?

“…Therefore, the findings of the present study should be further confirmed in future prospective studies that use psychometrically well-defined instruments that have been validated for the assessment of each specific pain rather than for assessment of overall pain. Consistent with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations [63], future studies should also consider including an expanded assessment of pain interference and emotional function.…”

Acupuncture versus Sham Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain

“…Combined, the primary and secondary endpoints addressed all recommended outcome domains for chronic pain trials 6 .…”

Partner Behavioral Responses to Pain Mediate the Relationship Between Partner Pain Cognitions and Pain Outcomes in Women With Provoked Vestibulodynia

“…We also aimed to assess whether these behavioral responses mediated the relation between partner cognitions, pain, and depressive symptoms. Depressive symptoms have previously been shown to be more elevated in the PVD population and is an important painrelated outcome 20,38 One such relevant partner cognition is catastrophizing. Greater spousal catastrophizing has been associated with more patient pain in chronic pain and PVD samples [21][22][23] , but the mechanism underlying this relationship has not been investigated.…”