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Clinical Trial NCT07278323 (FSHRT) for Adhesive Capsulitis of the Shoulder, Frozen Shoulder is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of California, San FranciscoFrozen Shoulder and Hormone Replacement Therapy (FSHRT) Phase 4 60
Clinical Trial NCT07278323 (FSHRT) is designed to study Treatment for Adhesive Capsulitis of the Shoulder, Frozen Shoulder. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on January 1, 2026 until the study accrues 60 participants. Led by University of California, San Francisco, this study is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on December 12, 2025.
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 peri...Show More
Detailed Description
Adhesive capsulitis of the shoulder (ACS), also known as frozen shoulder, affects up to 5% of the population with most cases occurring in peri- and postmenopausal women. This condition is debilitating, negatively impacting quality of life, yet current treatments are insufficient. There are mechanistic studies and biological plausibility to suggest the onset of this condition is associated with hormonal involvement, s...Show More
Official Title
Hormone Replacement Therapy as an Adjunct Treatment for Adhesive Capsulitis of the Shoulder (Frozen Shoulder) in Peri- and Postmenopausal Women
Conditions
Adhesive Capsulitis of the ShoulderFrozen ShoulderPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- FSHRT
- 25-44965
NCT ID Number
Start Date (Actual)
2026-01-01
Last Update Posted
2025-12-12
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Frozen Shoulder
Hormone Replacement Therapy
Perimenopause
Hormone Replacement Therapy
Perimenopause
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHormone 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. | 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...Show More 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. |
Active ComparatorStandard Care Participants will receive standard care for frozen shoulder including a steroid injection at the shoulder and referral to physical therapy | 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...Show More 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 Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
American Shoulder and Elbow Surgeons (ASES) Shoulder Function Scores | Pain in affected shoulder measured on the American Shoulder and Elbow Surgeons (ASES) shoulder function scale. Scores range from 0 to 100 with 0 indicating the lowest level of shoulder function and 100 indicating the highest level of shoulder function. | 6 months |
Shoulder range of motion via goniometry measures. | Investigators will assess the degree of flexion, extension, adduction, and abduction in the shoulder to determine range of motion. | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
40 Years
Eligible Sexes
Female
- Diagnosis of adhesive capsulitis of the shoulder
- History of hormone sensitive cancer
- Bilateral adhesive capsulitis of the shoulder
- Currently using hormonal treatments including contraceptives
University of California, San Francisco701 active studies to exploreStudy Central Contact
Contact: Alexa J Chandler, PhD, (415) 353-2808, [email protected]
1 Study Locations in 1 Countries
California
UCSF Orthopaedic Institute, San Francisco, California, 94158, United States
Alexa J Chandler, PhD, Contact, 415-353-2808, [email protected]
Stephanie E Wong, MD, Contact, (415) 353-2808, [email protected]