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.

Conflict of interest statement

Declaration of authorship and conflict of interest: All authors declare to meet the conditions for authorship. M.J.P. and R.B. conceived the study design. J.E.M., D.E.B., S.E.G., N.B.J., M.L., and A.P.V. provided input on the study design. M.J.P., S.S., and J.D. extracted data. M.J.P and R.B. classified outcome measurement instruments into domains. M.J.P. and J.E.M. undertook the statistical analyses. M.J.P. wrote the first draft of the article. All authors contributed to revisions of the article. All authors approved the final version of the submitted article. S.E.G and R.B are authors of two trials included in this review but were not involved in the eligibility assessment or data extraction of these two trials. All other authors declare no competing interests.

Copyright © 2015 Elsevier Inc. All rights reserved.

Figures

Fig. 1

Flow diagram of identification, screening, and inclusion of trials.

Fig. 2

Smoothed scatterplots of outcome domain use over time. Solid lines are smoothed values calculated from the nonparametric regression method locally weighted scatterplot smoothing (lowess), using a bandwidth of 0.8. Smoothed values falling outside of range (1) are not displayed. Observed values are binary (outcome reported or not reported) but are presented with some noise, so that individual observations are distinguishable (black points).