Objective To compare the effects of a programme of load management education plus exercise, corticosteroid injection use, and no treatment on pain and global improvement in individuals with gluteal tendinopathy.
Design Prospective, three arm, single blinded, randomised clinical trial.
Setting Brisbane and Melbourne, Australia.
Participants Individuals aged 35–70 years, with lateral hip pain for more than 3 months, at least 4/10 on the pain numerical rating scale, and gluteal tendinopathy confirmed by clinical diagnosis and MRI; and with no corticosteroid injection use in previous 12 months, current physiotherapy, total hip replacement, or neurological conditions.
Interventions A physiotherapy led education and exercise programme of 14 sessions over 8 weeks (EDX; n=69), one corticosteroid injection (CSI; n=66), and a wait and see approach (WS; n=69).
Main outcomes Primary outcomes were patient reported global rating of change in hip condition (on an 11 point scale, dichotomised to success and non-success) and pain intensity in the past week (0=no pain, 10=worst pain) at 8 weeks, with longer term follow-up at 52 weeks.
Results Of 204 randomised participants (including 167 women; mean age 54.8 years (SD 8.8)), 189 (92.6%) completed 52 week follow-up. Success on the global rating of change was reported at 8 weeks by 51/66 EDX, 38/65 CSI, and 20/68 WS participants. EDX and CSI had better global improvement scores than WS (risk difference 49.1% (95% CI 34.6% to 63.5%), number needed to treat 2.0 (95% CI 1.6 to 2.9); 29.2% (13.2% to 45.2%), 3.4 (2.2 to 7.6); respectively). EDX had better global improvement scores than CSI (19.9% (4.7% to 35.0%); 5.0 (2.9 to 21.1)). At 8 weeks, reported pain on the numerical rating scale was mean score 1.5 (SD 1.5) for EDX, 2.7 (2.4) for CSI, and 3.8 (2.0) for WS. EDX and CSI participants reported less pain than WS (mean difference −2.2 (95% CI −2.89 to −1.54); −1.2 (−1.85 to −0.50); respectively), and EDX participants reported less pain than CSI (−1.04 (−1.72 to −0.37)). Success on the global rating of change was reported at 52 weeks by 51/65 EDX, 36/63 CSI, and 31/60 WS participants; EDX was better than CSI (20.4% (4.9% to 35.9%); 4.9 (2.8 to 20.6)) and WS (26.8% (11.3% to 42.3%); 3.7 (2.4 to 8.8)). Reported pain at 52 weeks was 2.1 (2.2) for EDX, 2.3 (1.9) for CSI, and 3.2 (2.6) for WS; EDX did not differ from CSI (−0.26 (−1.06 to 0.55)), but both treatments did better than WS (1.13 (−1.93 to −0.33); 0.87 (−1.68 to −0.07); respectively).
Conclusions For gluteal tendinopathy, education plus exercise and corticosteroid injection use resulted in higher rates of patient reported global improvement and lower pain intensity than no treatment at eight weeks. Education plus exercise performed better than corticosteroid injection use. At 52 week follow-up, education plus exercise led to better global improvement than corticosteroid injection use, but no difference in pain intensity. These results support EDX as an effective management approach for gluteal tendinopathy.
Trial registration number Prospectively registered at the Australian New Zealand Clinical Trials Registry (ACTRN12612001126808).
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This article was first published in The BMJ. Cite this article as: BMJ 2018;361:k1662.
Contributors RM contributed to the study conception and design, recruitment of participants, management of study proceedings, data collection, and drafting and revision of the manuscript. AG, KB, and PH contributed to the study conception and design, and drafting and revision of the manuscript. PN contributed to the recruitment of participants, management of study proceedings, and data collection, and reviewed the manuscript. JK contributed to the statistical analysis and reviewed the manuscript. HW contributed to the study conception and design and reviewed the manuscript. BV contributed to the study conception and design, recruitment of participants, data management, and the drafting and revision of the manuscript. BV and RM act as guarantors and take responsibility for the integrity of the data and the accuracy of the data analysis. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. The senior author (BV) affirms that the manuscript is an honest, accurate and transparent account of the study being reported, that no aspects of the study have been omitted, and that any discrepancies from the study as planned/registered have been explained.
Funding This trial is funded by a National Health and Medical Research Council (NHMRC) programme grant (#631717). KB is supported by an NHMRC principal research fellowship (#1058440) and PH by an NHMRC senior principal research fellowship (#1002190). The funders of the study had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript or the decision to submit for publication.
Ethics approval Obtained from the human research ethics committees of the Universities of Queensland (#2012000930) and Melbourne (ID 1238598).
Data sharing statement Data and statistical analysis plan are available through mediated access at: https://espace.library.uq.edu.au/view/UQ:409744.