The MUSE Study for Menopausal Arthralgia

NCT06530459 | Recruiting Phase 2

• 1 other identifier: 2023/00727
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthralgia; Menopause; Perimenopausal Disorder; Joint Pain; Postmenopausal Disorder

Keywords

Menopausal hormone therapy; Muscle strength; Exercise; Randomized controlled trial; Midlife women

Outcome Measures

Primary Outcomes (1)

• Relative changes in perceived arthralgia at the end of intervention

  Relative changes in perceived arthralgia with the 10-item Örebro Musculoskeletal Pain Screening Questionnaire (Short Form) would be the pre-specified primary outcome parameter. Participants would be asked to rank each item on a 11-point scale from 0 to 10.

  After 12 weeks of intervention

Secondary Outcomes (10)

• Changes in Handgrip strength (kg)

  After 12 weeks of intervention

• Changes in isokinetic knee extension strength (degree/second)

  After 12 weeks of intervention

• Changes in physical performance using the Physical Performance Battery

  After 12 weeks of intervention

• Changes in associated menopausal symptoms using the Menopause Rating Scale (MRS)

  After 12 weeks of intervention

• Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI)

  After 12 weeks of intervention

Study Arms (4)

Exercise

EXPERIMENTAL

Curated exercises designed to address specific muscle groups and joints that are painful and problematic. Exercises would focus on upper and lower body strength generally. It is anticipated that 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.

Behavioral: Exercise training

Menopausal hormone therapy

EXPERIMENTAL

Menopausal hormone therapy comprising: 17beta-estradiol topical gel (1.25-2.5 gms) applied daily, and micronized Progesterone 200mg daily for 12 days each month.

Drug: Menopausal hormone therapy

Combination of exercise and menopausal hormone therapy

EXPERIMENTAL

1. Curated exercises designed to address specific muscle groups and joints that are painful and problematic. 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. 2. Menopausal hormone therapy comprising: 17beta-estradiol topical gel (1.25-2.5 gms) applied daily, and micronized Progesterone 200mg daily for 12 days each month.

Combination Product: Menopausal hormone therapy + exercise training

Standard care

NO INTERVENTION

Standard care will be provided.

Interventions

Menopausal hormone therapy DRUG

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

Menopausal hormone therapy

Exercise training BEHAVIORAL

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.

Exercise

Menopausal hormone therapy + exercise training COMBINATION_PRODUCT

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.

Combination of exercise and menopausal hormone therapy

Eligibility Criteria

• Age: 30 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Arthralgia; Motor Activity

Interventions

Hormone Replacement Therapy; Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Eu-Leong Yong, PhD

CONTACT

67724278; obgyel@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)