💬In plain words
What the trial is, and whether it could suit you
The investigators plan to conduct a pilot 4-arm, randomized study comprising the following interventions: muscle strengthening exercises (MSE) alone, estrogen therapy (ET) alone, and a combination of MSE and ET, compared to usual care in women with menopausal arthralgia. The aim of this pilot study is to assess the feasibility, patient acceptability, and patient perspectives and logistics of delivering interventions, and practicability of outcome assessment tools in this 4-arm study over a 12-week period.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
INCLUSION CRITERIA:
1. Patients with muscle stiffness and joint discomfort in various sites, including hands, knees, back, hips, and/or shoulders. Patients with pain in only one isolated joint would not be accepted.
2. Arthralgia symptoms with onset, or has become worse, over the perimenopausal or early postmenopausal period (within 5 years of the menopause).
3. Women should be at the menopause transition, less than or equal to 59 years old at the time of enrollment, or within 5 years of menopause whichever is earlier.
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4. Arthralgia for at least 3 months (pain lasting beyond normal injury healing period)
5. Community-dwelling and able to ambulate independently.
EXCLUSION CRITERIA:
1. History of thrombo-embolic diseases, strokes, ischemic heart disease, dementia or psychiatric disorders, active liver disease or renal impairment, severe hyperlipidemia, gout, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, or other chronic inflammatory conditions.
2. Pregnancy
3. Non-adherence to national guidelines for breast cancer screening
4. High risk for breast cancer
5. Any joint surgery within the last 6 months
6. Severe obesity: BMI\>35
7. Migraine with aura
8. Poorly controlled diabetes
9. Use of any form of female hormone supplementation within the past 12 weeks.
10. High venous thromboembolism risk
11. Current cholecystitis, fibroids, or undiagnosed abnormal uterine bleeding.
12. Current smoker.
13. History of endometrial, ovarian, peritoneal, cervical, breast or endocrine-dependent cancers.
14. Receiving treatment for any form of cancer.
15. History of fragility bone fractures within the 2 years.
16. Any other cognitive, musculoskeletal, neurological, and cardiorespiratory condition affecting one's ability to participate in the study.
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