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Frozen Shoulder and Hormone Replacement Therapy

NCT07278323 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

DRUG

Hormone Replacement Therapy (HRT)

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

DRUG

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.

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Stephanie E Wong, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278323 on ClinicalTrials.gov