A Phase 4 interventional study of Hormone Replacement Therapy (HRT) and Corticosteroid and 1%lidocain in Adhesive Capsulitis of the Shoulder and Frozen Shoulder, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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, specifically estrogen. Given hormone replacement therapy (HRT) is widely prescribed to women experiencing menopause-related symptoms, investigators propose using HRT as an adjunct treatment for ACS. The primary objective of this study is to evaluate patient-reported outcomes using the American Shoulder and Elbow Surgeons (ASES) score following treatment with HRT + standard care versus standard care alone. The secondary objective is to determine changes in range of motion (ROM) and functional workspace using both routine clinical metrics and a novel clinical marker-less movement analysis system. Investigators hypothesize that HRT can improve pain scores and ROM limitations in peri- and postmenopausal women who present with ACS. Investigators will recruit 60 women who are peri- or postmenopausal and employ a longitudinal randomized controlled trial to determine the effects of HRT + standard treatment on ACS symptom severity. All participants will receive standard care of physical therapy and a glenohumeral joint steroid injection; the experimental group will also receive HRT. Measures will be repeated after six months of treatments. Within- and between-group changes in pain scores, ROM, and functional workspace will be evaluated using repeated measures ANOVAs with Tukey's multiple comparisons test as indicated by treatment groups. An alpha level of 0.05 will be used to determine statistical significance for all measures. This pilot project will provide critical preliminary data to support future extramural funding applications to government agencies, foundations, and industry partners.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 346 interventional studies indexed under Bursitis.
Browse Bursitis studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Hormone Replacement Therapy (HRT) · Drug: Corticosteroid and 1%lidocain · Behavioral: physical therapy
Participants will receive standard care for frozen shoulder including a steroid injection at the shoulder and referral to physical therapy
Drug: Corticosteroid and 1%lidocain · Behavioral: physical therapy
Participants will receive HRT for 6 months consisting of 0.5mg estradiol skin patch and 100mg of oral daily progestin
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.
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.
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.
Time frame: 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.
Time frame: 6 months
Shoulder Functional Workspace
Kinectigram by Bioniks will be used to evaluate the functional workspace of the shoulder. This motion capture system assesses the ability of participants to reach with their hands to determine the total area the hand can reach relative to the shoulder.
Time frame: 6 months
Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
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