Recruiting

HRT with Standard Care

Sponsor:

UCLA

Code:

NCT07278323

Conditions

Adhesive Capsulitis of the Shoulder

Frozen Shoulder

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Hormone Replacement Therapy (HRT)

Corticosteroid and 1%lidocain

physical therapy

Study Details

Brief summary:

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.

Conditions

Adhesive Capsulitis of the Shoulder

Frozen Shoulder

Study ID

NCT07278323

Start date

Jan 15, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of adhesive capsulitis of the shoulder

Exclusion Criteria:

  • History of hormone sensitive cancer
  • Bilateral adhesive capsulitis of the shoulder
  • Currently using hormonal treatments including contraceptives

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Hormone Replacement Therapy (HRT)

Participants will receive HRT for 6 months consisting of 0.5mg estradiol skin patch and 100mg of oral daily progestin

Corticosteroid and 1%lidocain

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

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.

Primary outcome measure

  • American Shoulder and Elbow Surgeons (ASES) Shoulder Function Scores [ Time Frame: 6 months ]
  • Shoulder range of motion via goniometry measures. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Alexa J Chandler, PhD

(415) 353-2808alexa.chandler@ucsf.edu

Locations

UCSF Orthopaedic Institute

Recruiting

San Francisco, California, United States, 94158

Contacts

Alexa J Chandler, PhD

415-353-2808alexa.chandler@ucsf.edu

Stephanie E Wong, MD

(415) 353-2808stephanie.wong2@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Frozen Shoulder
  • Hormone Replacement Therapy
  • Perimenopause

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-08.