Study design Multicentre, double-blind, placebo-controlled randomised clinical trial.
Objectives To compare the effectiveness of long chain omega-3 polyunsaturated fatty acids (PUFAs) as part of the management for people diagnosed with rotator cuff related shoulder pain (RCRSP).
Summary of background Although there is no robust evidence to support their use, omega-3 PUFAs have been recommended for those with tendinopathy due to their potential to moderate inflammation.
Methods Participants with RCRSP (n=73) were randomised to take either nine MaxEPA capsules providing 1.53 g eicosapentaenoic acid, 1.04 g docosahexaenoic acid or nine matching placebo capsules containing oleic acid per day for 8 weeks. In addition, participants attended an exercise/education programme for 8 weeks. Participants were assessed at prerandomisation, 8 weeks (primary outcome point), 3 months, 6 months and 12 months (secondary outcome point). Primary outcome was the Oxford Shoulder Score (OSS). Secondary outcomes included the Shoulder Pain and Disability Index (SPADI), Patient Specific Functional Score, Euro Qol 5D-3L, Short Form 36, global rating of change and impairment measurements. Analysis was by intention to treat.
Results Difference in the change in the OSS between the two groups at 2 months was –0.1 (95% CI −2.6 to 2.5, p=0.95). The change in SPADI scores was −8.3 (95% CI −15.6 to −0.94, p=0.03, analysed by analysis of covariance adjusted for baseline) at 3 months.
Conclusion Omega-3 PUFA supplementation may have a modest effect on disability and pain outcomes in RCRSP.
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Contributors The initial idea for this study was generated by JL. FS, TS and JL have contributed to the planning of the manuscript and the planning of the study. FS has written the paper and this has been reviewed by all contributing authors. Data collection was conducted by HW and FS.
Funding Seven Seas Ltd provided the active and placebo capsules for this study. There was no other funding for this study.
Competing interest None declared.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement There is no additional information to be made available for data sharing.
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