Does menopausal hormone therapy (MHT), exercise or a combination of both, improve pain and function in post-menopausal women with greater trochanteric pain syndrome (GTPS)? A randomised controlled trial.

Charlotte Ganderton,Jill Cook,Tania Pizzari,Adam Semciw

doi:10.1186/s12905-016-0311-9

Charlotte Ganderton, Jill Cook + Show 2 more

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https://doi.org/10.1186/s12905-016-0311-9

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Abstract

BackgroundGreater trochanteric pain syndrome (GTPS) is pathology in the gluteus medius and minimus tendons and trochanteric bursa that causes debilitating tendon pain and dysfunction, particularly in post-menopausal women. Limited evidence in clinical studies suggests hormone changes after menopause may have a negative effect on tendon. This protocol describes a randomised controlled trial comparing the effectiveness of menopausal hormone therapy (MHT) and exercise therapy in reducing pain and dysfunction associated with GTPS in post-menopausal women.MethodOne hundred and sixteen post-menopausal women will be recruited and randomised to receive one of two exercise programs (sham or targeted intervention exercise) and transdermal creams (MHT cream containing oestradiol 50mcg and norethisterone acetate 140mcg or placebo cream). Interventions will be 12-weeks in duration and outcomes will be examined at baseline, 12-weeks and 52-weeks. The primary outcome measure will be the VISA-G questionnaire and secondary outcomes measures will include three hip pain and function questionnaires (Hip dysfunction and Osteoarthritis Outcome Score, Oxford Hip Score, Lateral Hip Pain questionnaire), a global change in symptom questionnaire (using a 15-point Likert scale) and a quality of life measure (AQoL-8D questionnaire). Data will be analysed using the intention to treat principle.DiscussionThis study is the first randomised controlled trial to compare the effectiveness of menopausal hormone therapy therapy alone, and with the combination of exercise therapy, to treat pain and dysfunction associated with GTPS. This study has been pragmatically designed to ensure that the interventions in this study can be integrated into policy and clinical practice if found to be effective in the treatment of GTPS in post-menopausal women. If successful, there is potential for this treatment regimen to be explored in future studies of other persistent tendon conditions in the post-menopausal population.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12614001157662 Registered 31 October 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s12905-016-0311-9) contains supplementary material, which is available to authorized users.

Highlights

Greater trochanteric pain syndrome (GTPS) is pathology in the gluteus medius and minimus tendons and trochanteric bursa that causes debilitating tendon pain and dysfunction, in post-menopausal women
This study is the first randomised controlled trial to compare the effectiveness of menopausal hormone therapy therapy alone, and with the combination of exercise therapy, to treat pain and dysfunction associated with GTPS
The aim of this study is to investigate the effect of menopausal hormone therapy and exercise on pain and function in postmenopausal women with GTPS

Summary

Introduction

Greater trochanteric pain syndrome (GTPS) is pathology in the gluteus medius and minimus tendons and trochanteric bursa that causes debilitating tendon pain and dysfunction, in post-menopausal women. Limited evidence in clinical studies suggests hormone changes after menopause may have a negative effect on tendon This protocol describes a randomised controlled trial comparing the effectiveness of menopausal hormone therapy (MHT) and exercise therapy in reducing pain and dysfunction associated with GTPS in post-menopausal women. The reported incidence of GTPS is 1.8 per 1000 patients per year in primary care [2] and prevalence rates of 23.5 % in women at risk of knee osteoarthritis [3] and 54 % in recipients of renal transplants [4]. It is feasible that supplemental oestrogen in the postmenopausal population may preserve tendon collagen [8] and decrease tendon abnormality [6]

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