Hormone therapy with exercise and education on pain and function in postmenopausal women with subacromial pain syndrome (rotator cuff related shoulder pain). A pilot randomised clinical trial.

Intervention group: Postmenopausal women with subacromial pain syndrome will be randomised into MHT or placebo groups. The MHT group will receive combined daily transdermal oestrogen plus daily oral progesterone (Estrogel Pro combined pack or transdermal oestrogen gel 1.5mg per dose daily with oral micronised progesterone capsule 100mg). Gel will be applied and capsule taken once daily for the duration of the 12-week intervention period. Consistent with best practice guidelines, both groups will receive physiotherapy involving an isometric scapular-focused rotator-cuff strengthening program, with progressive tendon loading (Kinsella et al., 2017) and education about avoidance of rotator cuff tendon and bursa compression. All participants will enter a 12-week intervention period, with physiotherapy appointments at baseline, 1, 2, 4, 6 and 9 weeks. Physiotherapy appointments will be one:one, with a 40 minute initial appointment and 30 minute reviews. Participants will perform their prescribed exercise program (approx 20 minutes) 1-2 x daily for the duration of the program. The exercise intervention involves the following 5 components, where exercises are introduced and progressed as clinically appropriate (from the EMPOWER exercise protocol and as determined by the treating physiotherapist): 1) Scapular setting exercises 2) Isometric rotator cuff exercises 3) Concentric rotator cuff strength progressions 4) Posterior musculature strengthening 5) Optional flexibility stretches (thoracic and lateral neck) Participants commence with scapular setting exercises and progress through isometric rotator cuff, concentric rotator cuff, posterior muscle strengthening and appropriate flexibility (when clinically indicated) exercises. All treating physiotherapists received standardised training over a 2 hour in person training session (delivered by 2 x Chief Investigators both senior musculoskeletal physiotherapists and clinician researchers), which was delivered in December 2025. The training session covered specifics regarding delivery of the exercise intervention, including education and appropriate progressions/regressions as clinically indicated. An optional follow up 1 hour session was delivered in February 2026 to ensure all treating physiotherapists were trained in administrative requirements and given an opportunity to ask questions. A detailed training manual has been developed and will be provided to all treating physiotherapists. The manual includes detailed information regarding the exercise protocol, appropriate modifications, permitted manual therapies (over a maximum of 2 sessions), education, and IMP administration. Blinding and post intervention period: Participants, clinicians and lead researcher will be blinded to intervention group throughout the duration of the 12-week intervention and until 26-week follow-up. At the completion of the 12-week intervention period, participants are permitted to seek MHT prescription from their medical practitioner or menopause clinic but will remain blinded to group allocation until 26 weeks. Adherence: A standardised daily adherence diary (to both the MHT/placebo and exercise) will be maintained by all participants. Blinding: A standardised success of blinding email will be sent to each participant 4 weeks following commencement of the trial.