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.
La Trobe University
120 participants
Mar 5, 2015
Interventional
Conditions
Summary
Greater trochanteric pain syndrome (GTPS) causes severely debilitating pain on the outside of the hip, resulting in limited activity, employment and decreased capacity to exercise. The pain of GTPS has been shown to be as severe and debilitating as osteoarthritis of the hip in those waiting for hip replacement. It most commonly affects post-menopausal women and limits capacity for physical activity that is critical for older women to achieve healthy ageing. In addition to tendon injury, ageing women suffer a myriad of conditions and diseases that burden both the individual and society, all of which can be ameliorated by physical activity (cardiovascular disease, obesity and osteoporosis). Conservative management is the first line treatment, although evidence is limited and the condition can be resistant to treatment. Thus, the aim of this study is to investigate the effect of menopausal hormone therapy and exercise on pain and function in post-menopausal women with GTPS. Eighty women will be recruited and randomised to one of four groups: (i) Exercise therapy, placebo MHT cream; (ii) Sham exercise, MHT cream; (iii) Sham exercise, placebo MHT cream or (iv) Exercise therapy, MHT cream. Interventions will be 12 weeks in duration and outcomes (6 questionnaires) will be examined at baseline, 3 months, and 12 months. We hypothesise that as tendon cells contain hormone-specific receptors, supplemental hormones may be beneficial for reducing pain and dysfunction measured by a clinical significant change in VISA-G scores (using responder analysis).
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
Once eligible for the trial, participants will be recruited and randomised into one of the following 12 week interventions: (i) Exercise therapy, placebo transdermal cream (ii) Sham exercise, transdermal MHT cream (iii) Sham exercise, placebo transdermal cream (iv) Exercise therapy, MHT transdermal cream. Interventions 1. Menopausal hormone therapy (MHT) transdermal cream. The MHT cream is based on the Estalis continuous active ingredients. This involves supplementation of oestradiol (50mcg) and norethindrone acetate (NETA) (140mcg), a progestin. This has been chosen as it closely mimics the normal female hormone fluctuations over a monthly cycle and the progestin component provides important protection of the uterus. The active ingredients used in this cream are widely available as used commercially in a transdermal patch. A cream formula was chosen so that its appearance and texture is identical to that of the placebo alternative. Participants will be instructed to apply 1g of cream to the skin in the inner wrist region daily for 12 weeks, rotating sides every 5 days (left and right arm). Dispensing equipment will accurately measure the correct amount to ensure accurate administration. 2. Intervention exercise therapy: Participants randomised into the intervention exercise group will be instructed in a 12 week gluteal tendon exercise program designed by clinicians expert in treating tendon pathology as there is a lack of evidence available on effective exercise therapy in GTPS. Participants will attend 4 physiotherapy sessions (baseline, 4 weeks, 8 weeks and 12 weeks post randomisation) for progression of their home exercise program and monitoring of compliance. Participants will complete their prescribed home exercise program twice daily and record their compliance with the program in an exercise diary. There is no set duration for each stage of the exercise program - progression is determined by the treating physiotherapist and is dependent on a participant's ability to complete the precribed exercises. A participant should expect their exercise session to take approximately 10-15 minutes to complete their exercise program. Stage 1: i. Gluteus medius strengthening: Hip Hitch with wall support and progress to hip hitch off the wall with arm support. Commence with 2 x 15second holds and increase to 4 x 40second holds before progressing to stage 2. ii. Quadriceps strengthening: Double leg 1/4 wall squats with Hip externally rotated 20degrees, progressively increased to 1/2 wall squat. Commence with 1 set of 5 repetitions and increase to 4 sets of 5 repetitions before progressing to stage 2. iii. Calf strengthening: Bilateral calf raise with arm support for balance. Commence with 2 sets of 5 repetitions and increase to 2 x 10 repetitions before progressing to stage 2. Stage 2: i. Gluteus medius strengthening: Hip Hitch with toe taps onto 7.5cm step, progressing to a 10cm step. Commence with 2 sets of 5 repetitions and increase to 2 x 15 repetitions before progressing to stage 3. ii. Quadriceps strengthening: Sit to stand off a standard chair with arms accross chest, progressively decreasing the height of the chair as tolerated. Commence with 1 set of 5 repetitions and increase to 2 x 10 repetitions before progressing to stage 3. iii. Calf strengthening: Sustained calf raise with toe rises on the spot, using arms for balance. Commence with 2 sets of 5 repetitions and increase to 2 x 10 repetitions before progressing to stage 3. Stage 3: i. Gluteus medius strengthening: Hip Hitch with hip swing. Commence with hip hitch sustained hold on the affected (stance) limb. Complete hip swings 10deg fowards and backwards 5 times with the contralateral leg. Increase this to 2 sets of 15 contralateral hip swings before progressing to advanced exercises. ii. Quadriceps strengthening: Sit to stand off a standard chair with bias to affected leg by positioning it more posteriorly to the unaffected leg. Commence with 2 x 5 repetitions and increase to 4 x 5 repetitions before progressing to advanced exercises. iii. Calf strengthening: Single leg calf raise using arms for balance. Commence with 2 x 5 repetitions and increase to 4 x 5 repetitions before progressing to advanced exercises. Advanced exercises: i. Gluteus medius strengthening: Single leg wall squat. 2 sets of 5 repetitions. ii. Quadriceps strengthening: Step ups. 2 sets of 10 repetitions. iii. Calf strengthening:Single leg calf raise using arms for balance. 2 sets of 15 repetitions. In addition, a booklet that features photos and explanations of each exercise will be given to each participant for further reference. These exercises will be completed twice daily. Participants will document program adherence to exercise and MHT in a diary. Any adverse reactions will immediately be referred to a medical practitioner for assessment. All participants will continue normal activities but will be asked to record medication use (analgesic or anti-inflammatory) for their tendinopathy (e.g. NSAIDs) and cease adjunct treatments/physical treatment (physiotherapy, dry needling, accupuncture etc.). Failure to improve: Participants will be offered cross over to both active interventions if their global rating of change score is below 0 (worsened symptoms) at 12 weeks. If in GLoBE exercise and placebo cream, they will cross over to intervention cream and continue GLoBE exercise. If in sham exercise and placebo cream, they will cross over to GLoBE exercise and intervention cream, if in sham exercise and intervention cream, they will cross over to GLoBE exercise and continue intervention cream once cleared to do so by study medical practitioners. Results for this group will be analysed and presented separately.
Locations(1)
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ACTRN12614001157662