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.

Phase 2

Completed

• Conditions: Greater Trochanteric Pain Syndrome (GTPS); Musculoskeletal - Other muscular and skeletal disorders; Physical Medicine / Rehabilitation - Physiotherapy

• Registration Number: ACTRN12614001157662
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-31
• Study Completion: 2019-12-20
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

Included participants must be post-menopausal, determined by >12 months of menstruation cessation and/or a serum oestradiol of 0-120pmol/L and an FSH of >20IU/L; have a clinical diagnosis of GTPS; have lateral hip pain reproduction on 3/5 clinical tests (trendenburg test, FABER, palpation of the greater trochanter, resisted external de-rotation test, modified resisted external de-rotation test) and have sufficient English skills to be able to read and understand the information and consent form due to the risks involved with participating in the study.

Exclusion Criteria

Participants will be excluded by the medical practitioner if they are known to have an adverse reaction to any form of hormone therapy or have used any form of female hormone supplementation within the last 3 months; have a high risk of DVT / PE; are a current smoker; have an HbA1c >7% and/or fasting glucose > 6mmol/L; have a history of stroke, severe menstrual migraine, endometrial sarcoma, breast cancer, severe hyperlipidaemia, chronic liver disease, lupus; have had a hysterectomy; have current cholecystitis or undiagnosed abnormal uterine bleeding. Additionally, participants will be excluded if they have had a platelet-rich plasma (PRP), autologous blood injection (ABI) or corticosteroid injection (CSI) in the hip region in the last 3 months and or have any musculoskeletal, neurological and cardiorespiratory conditions affecting a their ability to participate in the study.

Where a participant meets inclusion criteria and has not had a PRP, ABI or CSI in the hip region in the last 3 months, but is excluded from the hormone intervention on medical grounds, they will be randomised into a single arm (intervention exercise or sham exercise).

Study & Design

• Study Type: Interventional
• Study Design: Not specified