Does Menopausal Hormone Therapy, Exercise, or Both Improve Pain and Function in Postmenopausal Women With Greater Trochanteric Pain Syndrome? A 2 × 2 Factorial Randomized Clinical Trial

Abstract

Background: Greater trochanteric pain syndrome (GTPS) is a debilitating chronic condition, most prevalent in postmenopausal women. A positive association between high estrogen levels and tendon health may exist, and postmenopausal women have reduced estrogen. Menopausal hormone therapy (MHT) may reduce the incidence of tendon abnormality, particularly when combined with exercise. Purpose: To determine the effect of MHT and exercise on tendon pain and function in postmenopausal women with GTPS. Study Design: Randomized controlled clinical trial; Level of evidence, 1. Methods: Postmenopausal women (N = 132; n = 12, lost to follow-up) with GTPS were randomized into MHT and placebo transdermal cream groups combined with tendon-specific or sham exercise. All groups received education about avoiding gluteal tendon compression and load management throughout 12 weeks of intervention. The primary outcome was the Victorian Institute of Sport Assessment for gluteal tendinopathy (VISA-G), and secondary outcomes were measured at baseline and at 12 and 52 weeks. The Global Rating of Change was assessed at 12 and 52 weeks. A linear mixed-effects model was used to assess differences. Body mass index (BMI) was included as a covariate. Results: All participant groups improved over time (baseline vs 12 weeks, P < .001; baseline vs 52 weeks, P < .001). There was no difference among exercise groups measured by all outcomes (VISA-G: baseline, P = .97, mean difference [MD] = 0.10; 12 weeks, P = .49, MD = 2.15; 52 weeks, P = .32, MD = −3.08). There was a significant interaction effect between cream and BMI; therefore, the population was stratified by BMI levels (<25, <30, ≥30). The MHT groups (with exercise and education) had significantly better VISA-G outcomes (baseline, P = .04, MD = −11.20, 95% CI = −21.70 to −0.70; 12 weeks, P < .001, MD = −20.72, 95% CI = −31.22 to −10.22; 52 weeks, P = .002, MD = −16.71, 95% CI = −27.21 to −6.22) and secondary measure scores as compared with placebo at all time points when BMI was <25. Conclusion: MHT or placebo combined with tendon-specific or sham exercise plus education reduced pain and increased function for this population. For women with a BMI <25, MHT with any exercise plus education was better than placebo. A targeted exercise or sham exercise strategy is effective when prescribed with education about avoiding gluteal tendon compression and load management. Registration: ACTRN12614001157662 (Australian New Zealand Clinical Trials Registry).