Frozen Shoulder and Hormone Replacement Therapy

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07278323
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Adhesive Capsulitis of the Shoulder
  • Frozen Shoulder

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hormone Replacement Therapy (HRT) — DRUG
    Participants will receive HRT for 6 months consisting of 0.5mg estradiol skin patch and 100mg of oral daily progestin
  • Corticosteroid and 1%lidocain — DRUG
    Ultrasound-guided glenohumeral joint injections will be performed in clinic by a board-certified fellowship-trained primary care sports medicine physician with expertise performing ultrasound-guided joint injections. Injections will be performed using standard aseptic technique after obtaining informed consent. For local anesthesia, 1 mL of 1% lidocaine will be injected with a 25 gauge 2-inch needle into the skin and subcutaneous tissues. Following this, a 22 gauge 2.5-inch needle will be used to inject a 5 mL combination of 1 mL of 40 mg/mL triamcinolone, 2 mL of 0.2% ropivacaine, and 2 mL of normal saline into the glenohumeral joint.
  • physical therapy — BEHAVIORAL
    Patients will be referred to physical therapy to complete on their own and will be given an at home program to follow while they wait to see therapists.

Study Details

The purpose of this study is to determine the effects of hormone replacement therapy (HRT) in addition to standard treatment on frozen shoulder symptoms in women with age-related changes to their menstrual cycle. Frozen shoulder refers to the condition a doctor diagnosed the participant with regarding shoulder pain, stiffness, and progressive loss of range of motion. Age-related menstrual cycle changes, known as perimenopause and/or menopause, refers to a change or stoppage of monthly menstrual cycles. Other symptoms participants may be experiencing include vaginal dryness, hot flashes, or night sweats. Hormone replacement therapy (HRT) refers to medicine with female hormones in it. For this study, HRT will be in the form of a patch that goes on the skin and a daily oral pill. Participants will be randomly assigned to receive either HRT plus standard care, or only standard care. Follow-up tests will be completed at 6 months of treatment to assess participant progress.

Key Dates

Start date
Jan 15, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hormone Replacement Therapy plus standard care
    Participants will be prescribed HRT for 6 months (estrogen patch and oral progestin) in addition to receiving a steroid injection at the shoulder and referral to physical therapy.
  • Active Comparator: Standard Care
    Participants will receive standard care for frozen shoulder including a steroid injection at the shoulder and referral to physical therapy

Primary Outcome Measure

American Shoulder and Elbow Surgeons (ASES) Shoulder Function Scores [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Orthopaedic InstituteSan FranciscoCalifornia94158
Alexa J Chandler, PhD
[email protected]
415-353-2808
Stephanie E Wong, MD
[email protected]
(415) 353-2808

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By research site
UCSF Orthopaedic Institute· San Francisco, CA

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