Background: Greater trochanteric pain syndrome (GTPS) is a debilitating condition, prevalent in post-menopausal women. A positive association between high oestrogen levels and tendon health may exist. Menopausal hormone therapy (MHT) could reduce the incidence of tendon abnormality in post-menopausal women, particularly when combined with exercise. This blinded 2 x 2 factorial randomised clinical trial (GLoBE Hip Trial) aimed to determine the effect of MHT and exercise on tendon pain and function in post-menopausal women with GTPS.
Methods: A total of 132 post-menopausal women (mean age 61.1±6.4 years, BMI 28.6±5.43) with GTPS were randomised into either MHT (oestradiol 50mcg and norethisterone acetate 140mcg) or placebo transdermal cream groups and either tendon-specific/GLoBE or sham exercise groups for a 12-week intervention period. All groups received education on avoiding gluteal tendon compression. Primary (Victorian Institute of Sport Assessment – Gluteal Tendon (VISA-G)) and secondary (Assessment of Quality of Life, Hip Disability and Osteoarthritis Outcome Score, Oxford Hip Score, Global Rating of Change) outcomes were measured at baseline, 12 and 52 weeks. A linear mixed effects model (of best fit) was used to compare groups at each time point and changes over time. Body mass index (BMI) was included as a covariate.
Results: All groups improved over time, regardless of intervention. There was no difference between targeted or sham exercise or MHT and placebo creams (raw unadjusted and including BMI as covariate) at each timepoint. VISA-G outcome was significantly associated with BMI (p=0.003) and there was a significant interaction effect between cream and BMI (p=0.03). The population was therefore stratified based on BMI (<25, <30, ≥30 ). The MHT groups (with exercise and education) had significantly better VISA-G (baseline p=0.04, MD=-11.2, 95%CI=-21.70:-0.70, 12 weeks p<0.00, MD=-20.72, 95%CI=-31.22:-10.22, 52 weeks p<0.00, MD=-16.71, 95%CI=-27.21:-6.22) and secondary measure scores compared to placebo at all timepoints when BMI<25.
Discussion: MHT or placebo combined with tendon-specific or sham exercise plus education reduced pain and increased function for this population. Women with BMI<25 who were allocated MHT with any exercise plus education were better than placebo cream. MHT may be an effective intervention for post-menopausal women with GTPS when BMI <25 and when prescribed in conjunction with any exercise plus education. Any exercise strategy is effective when prescribed with education about avoiding gluteal tendon compression and load management.
Conflict of interest: None declared.