The MUSE Study for Menopausal Arthralgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Menopausal hormone therapy, Exercise training, Menopausal hormone therapy + exercise training.
- Who it may be relevant to
- Registry conditions: Arthralgia, Menopause, Perimenopausal Disorder, Joint Pain. Basic parameters: 30 years — 59 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The MUScle Strengthening Exercises and Estrogen (MUSE) Randomized Controlled Trial for Menopausal Arthralgia
Overview
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.
Detailed description
Recruited participants will be randomized to one of the following arms for 12 weeks: usual clinical care, 17b-Estradiol/progesterone (ET) only, Muscle strengthening exercises (MSE) only, combination of MSE plus ET. All participants will be assessed at Baseline and at 12 weeks.
Estrogen therapy (ET): Participants would apply 17b-estradiol (1.25-2.5 gms/daily) gel transdermally to joints and muscles most affected by arthralgia for 12 weeks. Participants with intact uteri would also be issued micronized Progesterone 200mg tablets to be taken orally for 12 days each month. Medications would be dispensed by the National University Hospital (NUH) pharmacy.
Muscle strengthening exercises (MSE) Exercises would be demonstrated in person by qualified staff physiotherapists. All Participants would be given a standard strength training protocol, with additional tailored exercises targeting their pain conditions, abilities and personal preferences. Exercises would focus on upper and lower body strength generally. Participants would be encouraged to exercise every day, alternating between upper and lower body strength training following the curated exercises. Exercise regimes would be reinforced through weekly reminders, and posts through social media.
MSE plus ET: Participants randomized to combination of would have both treatments administered at the same time within the same intervention period of 12 weeks. In other words, participants would be instructed to do the curated exercises and apply 17b-estradiol (1.25-2.5 gms/daily) gel trans-dermally with micronized progesterone oral tablets.
Usual care: Participants would continue their usual daily routines and come for outcome assessments at baseline and 12 weeks.
Interventions
- Drug Menopausal hormone therapy
Apply 17 beta-Estradiol topical gel (1.25-2.5 gms) daily Ingest Micronized Progesterone 200mg daily for 12 days each month - Behavioral Exercise 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 product Menopausal 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
Primary outcome measures
- Relative changes in perceived arthralgia at the end of intervention [Time frame: After 12 weeks of intervention]
Secondary outcome measures (10)
- Changes in Handgrip strength (kg) [Time frame: After 12 weeks of intervention]
- Changes in isokinetic knee extension strength (degree/second) [Time frame: After 12 weeks of intervention]
- Changes in physical performance using the Physical Performance Battery [Time frame: After 12 weeks of intervention]
- Changes in associated menopausal symptoms using the Menopause Rating Scale (MRS) [Time frame: After 12 weeks of intervention]
- Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) [Time frame: After 12 weeks of intervention]
- Changes in anxiety symptoms using the GAD-7 [Time frame: After 12 weeks of intervention]
- Changes in depression symptoms using the CES-D [Time frame: After 12 weeks of intervention]
- Changes in perceived quality of life using the SF-12. [Time frame: After 12 weeks of intervention]
- Changes in verbal memory measured using the Hopkins Verbal Learning Test [Time frame: After 12 weeks of intervention]
- Changes in insulin resistance using HOMA-IR [Time frame: After 12 weeks of intervention]
Eligibility criteria
Inclusion criteria
- 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.
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- Arthralgia for at least 3 months (pain lasting beyond normal injury healing period)
- Community-dwelling and able to ambulate independently.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Singapore · 1 center
- National University Hospital — Singapore
Identifiers
NCT: NCT06530459 · 2023/00727