The MUSE Study for Menopausal Arthralgia

ConditionsArthralgia Menopause Perimenopausal Disorder Joint Pain Postmenopausal Disorder

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexFemale

Age30-59

SponsorNational University Hospital, Singapore

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

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
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.
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.

Treatment groups

100 Participants

are divided into 4 treatment groups

Group A: ExerciseExperimental treatment 1 intervention

Group B: Menopausal hormone therapyExperimental treatment 1 intervention

Group C: Combination of exercise and menopausal hormone therapyExperimental treatment 1 intervention

Group D: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame