In a PEDro blog in April 2021 we highlighted that Rachael Cowan and her co-authors had won the PEDro prize for the best trial presented at the World Physiotherapy Congress 2021. This factorial randomised trial sought to determine the effect of exercise plus education and the effect of menopausal hormone therapy on tendon pain and function in postmenopausal women with greater trochanteric pain syndrome. The trial has now been published in The American Journal of Sports Medicine, and we summarise the results in this blog.
Greater trochanteric pain syndrome is prevalent in women, particularly those who are post-menopausal. Several sources of evidence suggest that raising oestrogen levels may lead to better tendon health, especially when combined with exercise. Another effective regimen for greater trochanteric pain syndrome is exercise plus education; the type of exercise does not seem to matter much but load management and avoidance of gluteal tendon compression may be important. The aim of the trial by Cowan et al was to determine the effects of exercise and of menopausal hormone therapy, in combination and isolation, on tendon pain and function in post-menopausal women with greater trochanteric pain syndrome.
Post-menopausal women with greater trochanteric pain syndrome were recruited through health care professionals, community noticeboards, fitness centres and (social) media. To be eligible, they needed to report lateral hip pain with at least two of the following activities: lying on the affected side, sitting, moving from sitting to standing, and ascending/descending stairs or slope. Physiotherapists gave all participants education, which covered how to avoid compression of the gluteal tendon, load management during activities of daily living and exercise.
In the trial’s factorial design, participants were randomised to receive hormonal therapy or placebo, and were also randomised to receive an exercise regimen or sham. The hormone therapy cream dosage equated to the estradiol and norethindrone/norethisterone acetate dose in commercial transdermal patches. The exercise consisted of twice-daily 15-minute sessions that included gluteus medius, quadriceps and calf strengthening exercises with gluteal tendon loading and weightbearing kinetic chain strengthening. The sham exercise regimen was a low-load lower limb exercise program. The regimens continued for 12 weeks.
Outcomes (blinded where possible) were assessed at 12 weeks and 52 weeks after randomisation. The primary outcome measure was the 0-to-100 VISA-G measure of the severity of disability from greater trochanteric pain syndrome. Secondary measures included the Oxford Hip Score, the Hip Disability and Osteoarthritis Outcome Score, the Assessment of Quality of Life-8D and a global rating of change.
VISA-G scores improved in all groups, with no interaction effects between combinations of hormone therapy and exercise. The secondary outcomes also did not demonstrate any clear differences between these interventions, alone or in combination. However, among women with a body mass index in the normal or underweight range, hormone therapy did induce better VISA-G scores by a mean of 21 points (95% CI 10 to 31) at 12 weeks and by a mean of 17 points (95% CI 6 to 27) at 52 weeks, regardless of whether the exercise or sham exercise had been allocated. Similarly, among women in this weight range, hormone therapy also induced better results on several of the secondary outcome measures, when added to the education given to all groups and whichever exercise had been allocated.
Cowan RM, et al. 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. Am J Sports Med 2021 Dec 13:Epub ahead of print.
