Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials

Abstract

Objectives: To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain).

Study design and setting: We included trials comparing physical therapy to any other intervention for shoulder pain, indexed up to March 2015 in CENTRAL, MEDLINE, EMBASE, or CINAHL Plus. Two authors independently selected trials for inclusion and extracted information on the domains and measurement instruments reported.

Results: We included 171 trials. Most trials measured pain (87%), function (72%), and range of movement (67%), whereas adverse events, global assessment of treatment success, strength, and health-related quality of life were measured in 18-27% of trials, and work disability and referral for surgery were measured in less than 5% of trials. Thirty-five different measurement instruments for pain and 29 for function were noted. Measurement of function increased markedly from 1973 to 2014. In rotator cuff disease trials, there was a more frequent measurement of pain and strength and a less frequent measurement of range of movement compared with adhesive capsulitis trials.

Conclusions: There was wide diversity in the domains and measurement instruments reported. Our results provide the foundation for the development of a core domain and outcome measurement set for use in future shoulder pain trials.

Keywords: Clinical trial; Outcome assessment (health care); Physical therapy modalities; Research methodology; Shoulder pain; Systematic review.