The MUSE Study for Menopausal Arthralgia

Last updated: July 26, 2024
Sponsor: National University Hospital, Singapore
Overall Status: Active - Recruiting

Phase

2/3

Condition

Arthritis And Arthritic Pain

Chronic Pain

Rheumatoid Arthritis

Treatment

Menopausal hormone therapy

Exercise training

Menopausal hormone therapy + exercise training

Clinical Study ID

NCT06530459
2023/00727
  • Ages 30-59
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

INCLUSION CRITERIA:

  1. Patients with muscle stiffness and joint discomfort in various sites, includinghands, knees, back, hips, and/or shoulders. Patients with pain in only one isolatedjoint would not be accepted.

  2. Arthralgia symptoms with onset, or has become worse, over the perimenopausal orearly postmenopausal period (within 5 years of the menopause).

  3. Women should be at the menopause transition, less than or equal to 59 years old atthe time of enrollment, or within 5 years of menopause whichever is earlier.

.

  1. Arthralgia for at least 3 months (pain lasting beyond normal injury healing period)

  2. Community-dwelling and able to ambulate independently.

Exclusion

EXCLUSION CRITERIA:

  1. History of thrombo-embolic diseases, strokes, ischemic heart disease, dementia orpsychiatric disorders, active liver disease or renal impairment, severehyperlipidemia, gout, thyroid disease, systemic lupus erythematosus, rheumatoidarthritis, 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-dependentcancers.

  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 conditionaffecting one's ability to participate in the study.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Menopausal hormone therapy
Phase: 2/3
Study Start date:
August 01, 2024
Estimated Completion Date:
April 30, 2028

Study 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.

Connect with a study center

  • National University Hospital

    Singapore,
    Singapore

    Active - Recruiting

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