Post-menopausal women - GLoBE hip trial
- Do you have pain at the side of your hip?
- Do you have trouble lying on your hip at night?
- Do you have pain in your hip climbing up and downstairs?
- Have you been diagnosed with bursitis of your hip, gluteal tendinopathy or greater trochanteric pain syndrome?
If you have answered to YES to one or more of these questions and you live in Melbourne metropolitan area or regional Victoria, you could be eligible for:
FREE PHYSIOTHERAPY & FREE MEDICAL ASSESSMENT
Please contact Rachael McMillan on (03) 9479 1389 or email email@example.com for further information.
Project title: Does hormone therapy, exercise or a combination of both, improve pain and function in post-menopausal women with greater trochanteric pain syndrome (GTPS)? A randomised controlled trial.
What is this study about and why is it important?
Greater trochanteric pain syndrome (gluteal tendinopathy) is a common condition that causes pain on the outside of your upper thigh/side of your hip. It can be a severely debilitating resulting in limited activity, employment and capacity to exercise. It is thought to be due to tears or injury to the gluteal tendons and/or inflammation of the fluid-filled sac (bursa) in your hip. Risk factors for developing the condition include female gender, middle age, increased weight, back pain and a reduced angle of your hip joint to your thigh bone. Conservative management is the first line treatment and usually involves one or more of corticosteroid (anti-inflammatory) injection, shockwave therapy and physiotherapy, with a focus on strengthening of your gluteal (bottom) muscles. However, there is limited evidence to indicate the effectiveness of these treatments. This study aims to determine if hormone therapy, exercise or a combination of both, assist in reducing the pain and dysfunction associated with greater trochanteric pain syndrome.
What does the research involve?
The study is investigating the effect of hormone replacement therapy and exercise on hip tendon health and the treatment of greater trochanteric pain syndrome.
- Phone screen to assess if you are eligible to participate in the trial
- Attend a free consultation with a sports and exercise doctor to ensure your condition is appropriate for the treatments we offer in this trial (hormone therapy and exercise).
- Blood test and an electrocardiograph: ECG (a non-invasive method of looking at the electrical activity of your heart) at your local Dorevitch Pathology collection centre.
- Following the analysis of these results which will be made available to the research investigators, you will be contacted if you are able to be a participant in the study.
- You will be randomly allocated to a hormone replacement therapy treatment group (oestradiol 50mcg and NETA 140mcg cream) or a placebo group, and one of two different exercise programs.
- A physiotherapist will explain your exercises to you and you will be provided with an exercise booklet and an exercise diary to ensure adherence to the program. Self-recording of exercise sessions and hormone therapy administration in a research diary is compulsory to ensure compliance with the exercise protocol.
During the trial
You will be required to attend four FREE 30-40 minute physiotherapy sessions (baseline, week 4, 8 and 12) during the trial. At these appointments, your exercise program will be reviewed and progressed to assist with the management of your condition.
After the 12 week intervention
- At 3 months, you will be required to undertake another blood sample.
- You will also be asked to complete questionnaires regarding your pain, function and quality of life at 3, and 12 months following the study. These measures are required to assess the effectiveness of the exercise therapy and hormone replacement therapy interventions.
What are the benefits of participating in this study?
- Free medical examination, including blood testing and ECG.
- Free clinical examination of your hip performed by a medical practitioner.
What are the possible benefits of participating in this study?
- Reduction in hip symptoms (pain and dysfunction)
- Improved function of your hip
- Improvement in your hip tendon health
- Improvements in quality of life measures
Additionally, completion of this project will enable us to assess if hormone replacement therapy has any role to play in the treatment of tendon pathology, and to determine which exercise program is more effective in treating pain and dysfunction associated with GTPS.
Who can I contact if I have any questions?
Questions concerning the procedure and/or rationale used in this investigation are welcome at any time. Please ask for clarification of any point, which you feel, is not explained to your satisfaction.
Please contact lead researcher, Rachael McMillan on (03) 9479 1389 or email firstname.lastname@example.org.
Ethics approval number UHEC 14-055.