Frozen Shoulder and Hormone Replacement Therapy

NCT07278323 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-44965
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Frozen Shoulder; Adhesive Capsulitis of the Shoulder

Keywords

Frozen Shoulder; Hormone Replacement Therapy; Perimenopause

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (1)

• Shoulder Functional Workspace

  6 months

Study Arms (2)

Hormone Replacement Therapy plus standard care

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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

Interventions

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.

Hormone Replacement Therapy plus standard care; Standard Care

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.

Hormone Replacement Therapy plus standard care; Standard Care

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

Hormone Replacement Therapy plus standard care

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Female patients are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of adhesive capsulitis of the shoulder

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Orthopaedic Institute

San Francisco, California, 94158, United States

Location

Related Publications (4)

• Klair JS, Yang JD, Abdelmalek MF, Guy CD, Gill RM, Yates K, Unalp-Arida A, Lavine JE, Clark JM, Diehl AM, Suzuki A; Nonalcoholic Steatohepatitis Clinical Research Network. A longer duration of estrogen deficiency increases fibrosis risk among postmenopausal women with nonalcoholic fatty liver disease. Hepatology. 2016 Jul;64(1):85-91. doi: 10.1002/hep.28514. Epub 2016 Apr 5.

  PMID: 26919573 BACKGROUND

• Hamed-Hamed D, Rodriguez-Perez C, Pruimboom L, Navarro-Ledesma S. Influence of the metabolic and inflammatory profile in patients with frozen shoulder - systematic review and meta-analysis. BMC Musculoskelet Disord. 2025 May 15;26(1):475. doi: 10.1186/s12891-025-08706-9.

  PMID: 40375116 BACKGROUND

• Kraal T, Lubbers J, van den Bekerom MPJ, Alessie J, van Kooyk Y, Eygendaal D, Koorevaar RCT. The puzzling pathophysiology of frozen shoulders - a scoping review. J Exp Orthop. 2020 Nov 18;7(1):91. doi: 10.1186/s40634-020-00307-w.

  PMID: 33205235 BACKGROUND

• Cogan CJ, Cevallos N, Freshman RD, Lansdown D, Feeley BT, Zhang AL. Evaluating Utilization Trends in Adhesive Capsulitis of the Shoulder: A Retrospective Cohort Analysis of a Large Database. Orthop J Sports Med. 2022 Jan 25;10(1):23259671211069577. doi: 10.1177/23259671211069577. eCollection 2022 Jan.

  PMID: 35097146 BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Hormone Replacement Therapy; Adrenal Cortex Hormones; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Rehabilitation

Study Officials

• Stephanie E Wong, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa J Chandler, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)