RecruitingPhase 2Phase 3NCT06530459

The MUSE Study for Menopausal Arthralgia

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

Sponsor

National University Hospital, Singapore

Enrollment

100 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Menopause Arthralgia Joint Pain Perimenopausal Disorder Postmenopausal Disorder

Summary

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.

Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 59 Years

Inclusion Criteria5

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.
Arthralgia symptoms with onset, or has become worse, over the perimenopausal or early postmenopausal period (within 5 years of the menopause).
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.
Arthralgia for at least 3 months (pain lasting beyond normal injury healing period)
Community-dwelling and able to ambulate independently.

Exclusion Criteria16

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.
Pregnancy
Non-adherence to national guidelines for breast cancer screening
High risk for breast cancer
Any joint surgery within the last 6 months
Severe obesity: BMI\>35
Migraine with aura
Poorly controlled diabetes
Use of any form of female hormone supplementation within the past 12 weeks.
High venous thromboembolism risk
Current cholecystitis, fibroids, or undiagnosed abnormal uterine bleeding.
Current smoker.
History of endometrial, ovarian, peritoneal, cervical, breast or endocrine-dependent cancers.
Receiving treatment for any form of cancer.
History of fragility bone fractures within the 2 years.
Any other cognitive, musculoskeletal, neurological, and cardiorespiratory condition affecting one's ability to participate in the study.

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Interventions

DRUGMenopausal hormone therapy

Apply 17 beta-Estradiol topical gel (1.25-2.5 gms) daily Ingest Micronized Progesterone 200mg daily for 12 days each month

BEHAVIORALExercise training

Exercises would focus on upper and lower body strength generally. It is anticipated that the participants ideally should exercise at least 3 times per week based on the strength training prescription. They could potentially exercise everyday, alternating between upper and lower body strength training. In all, there are up to 1-2 in-person therapy sessions and home sessions at least 3 times per week.

COMBINATION_PRODUCTMenopausal hormone therapy + exercise training

1. Apply 17 beta-Estradiol topical gel (1.25-2.5 gms) daily and Ingest Micronized Progesterone 200mg daily for 12 days each month 2. Exercises would focus on upper and lower body strength generally. It is anticipated that patients ideally should exercise at least 3 times per week based on the strength training prescription. They could potentially exercise everyday, alternating between upper and lower body strength training. In all, there are up to 1-2 in-person therapy sessions and home sessions at least 3 times per week.