Evaluating treatments for joint pain in menopausal women

The MUScle Strengthening Exercises and Estrogen (MUSE) Randomized Controlled Trial for Menopausal Arthralgia

This study is testing whether muscle strengthening exercises, estrogen therapy, or a combination of both can help relieve joint pain in women going through menopause.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 30 Years to 59 Years
• Sex: Female
• Sponsor: National University Hospital, Singapore (Academic / other)
• Locations: 1 site (Singapore)
• Trial ID: NCT06530459 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effectiveness of muscle strengthening exercises (MSE), estrogen therapy (ET), and a combination of both in alleviating arthralgia in women experiencing menopausal symptoms. Participants will be randomized into four groups: usual care, ET only, MSE only, and a combination of MSE and ET, with each intervention lasting 12 weeks. The study aims to assess feasibility, patient acceptability, and the practicality of outcome assessment tools. Participants will receive tailored exercise protocols and hormone therapy as needed, with assessments conducted at baseline and after 12 weeks.

Who should consider this trial

Good fit: Ideal candidates are women aged 59 or younger who are experiencing joint pain related to menopause and can ambulate independently.

Not a fit: Patients with a history of thrombo-embolic diseases, chronic inflammatory conditions, or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for joint pain in menopausal women, improving their quality of life.

How similar studies have performed: Other studies have shown promise in using similar approaches of combining exercise and hormone therapy for menopausal symptoms, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Singapore

• National University Hospital — Singapore, Singapore (Recruiting)

Study contacts

• Study coordinator: Eu-Leong Yong, PhD

Conditions Arthralgia; Menopause; Perimenopausal Disorder; Joint Pain; Postmenopausal Disorder; Menopausal hormone therapy; Muscle strength; Exercise