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Background: Greater 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.

Method: One 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.

Discussion: 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. 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 Registration: Australian New Zealand Clinical Trials Registry ACTRN12614001157662 Registered 31 October 2014.

Titel:	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.
Autor/in / Beteiligte Person:	Ganderton, C ; Semciw, A ; Cook, J ; Pizzari, T
Link:	Volltext (PDF) View record at Springer (Volltext)
Zeitschrift:	BMC women's health, Jg. 16 (2016-06-16), S. 32
Veröffentlichung:	[London] : BioMed Central, 2001-, 2016
Medientyp:	academicJournal
ISSN:	1472-6874 (electronic)
DOI:	10.1186/s12905-016-0311-9
Schlagwort:	Administration, Topical Australia Estradiol pharmacology Estradiol therapeutic use Female Hormone Replacement Therapy adverse effects Humans Middle Aged Norethindrone analogs & derivatives Norethindrone pharmacology Norethindrone therapeutic use Norethindrone Acetate Pain drug therapy Pain rehabilitation Pain Management standards Placebos administration & dosage Postmenopause drug effects Postmenopause physiology Quality of Life psychology Surveys and Questionnaires Clinical Protocols standards Exercise Femur abnormalities Hormone Replacement Therapy standards Pain Management methods
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Randomized Controlled Trial Language: English [BMC Womens Health] 2016 Jun 16; Vol. 16, pp. 32. <i>Date of Electronic Publication: </i>2016 Jun 16. MeSH Terms: Exercise* ; Clinical Protocols / standards ; Femur / abnormalities ; Hormone Replacement Therapy / standards ; Pain Management / methods ; Administration, Topical ; Australia ; Estradiol / pharmacology ; Estradiol / therapeutic use ; Female ; Hormone Replacement Therapy / adverse effects ; Humans ; Middle Aged ; Norethindrone / analogs & derivatives ; Norethindrone / pharmacology ; Norethindrone / therapeutic use ; Norethindrone Acetate ; Pain / drug therapy ; Pain / rehabilitation ; Pain Management / standards ; Placebos / administration & dosage ; Postmenopause / drug effects ; Postmenopause / physiology ; Quality of Life / psychology ; Surveys and Questionnaires References: Best Pract Res Clin Rheumatol. 2007 Apr;21(2):295-316. 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(PMID: 11476424) Contributed Indexing: Keywords: Exercise; Gluteal; Greater trochanteric pain syndrome; Hormone therapy; Oestrodiol; Post-menopausal; Tendinopathy Molecular Sequence: ANZCTR ACTRN12614001157662 Substance Nomenclature: 0 (Placebos) ; 4TI98Z838E (Estradiol) ; 9S44LIC7OJ (Norethindrone Acetate) ; T18F433X4S (Norethindrone) Entry Date(s): Date Created: 20160618 Date Completed: 20170808 Latest Revision: 20240528 Update Code: 20240528 PubMed Central ID: PMC4910216

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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.