Adhesive Capsulitis of the ShoulderPhase 4FSHRTNCT07278323
Frozen Shoulder and Hormone Replacement Therapy
A Phase 4 study testing Hormone Replacement Therapy (HRT), Corticosteroid and 1%lidocain and physical therapy in people with Adhesive Capsulitis of the Shoulder and Frozen Shoulder, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder, Frozen Shoulder
- What is being tested?
- Hormone Replacement Therapy (HRT), Corticosteroid and 1%lidocain and physical therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of adhesive capsulitis of the shoulder
Who cannot join
- History of hormone sensitive cancer
- Bilateral adhesive capsulitis of the shoulder
- Currently using hormonal treatments including contraceptives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSF Orthopaedic Institute
San Francisco, California, 94158
Alexa J Chandler, PhD, 415-353-2808, alexa.chandler@ucsf.edu
Stephanie E Wong, MD, (415) 353-2808, stephanie.wong2@ucsf.edu
About this study
Official title: Hormone Replacement Therapy as an Adjunct Treatment for Adhesive Capsulitis of the Shoulder (Frozen Shoulder) in Peri- and Postmenopausal Women
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.
Read the 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, 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.
- Being tested
- Hormone Replacement Therapy (HRT), Corticosteroid and 1%lidocain, physical therapy
- Keywords
- Frozen Shoulder, Hormone Replacement Therapy, Perimenopause
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Corticosteroid and 1%lidocainDrug
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Corticosteroid and 1%lidocain; Behavioral: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start15 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie E Wong, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278323
- Sponsor's protocol ID
- 25-44965
- Acronym
- FSHRT
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26919573Hamed-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.
PubMed 40375116Kraal 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.
PubMed 33205235Cogan 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.
PubMed 35097146
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Replacement Therapy as an Adjunct Treatment for Adhesive Capsulitis of the Shoulder (Frozen Shoulder) in Peri- and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07278323
- Acronym / sponsor ID
- FSHRT / 25-44965
- Keywords
- Frozen Shoulder, Hormone Replacement Therapy, Perimenopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormone Replacement Therapy plus standard care | Experimental | Drug: Hormone Replacement Therapy (HRT), Drug: Corticosteroid and 1%lidocain, Behavioral: physical therapyParticipants 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. |
| Standard Care | Active comparator | Drug: Corticosteroid and 1%lidocain, Behavioral: physical therapyParticipants will receive standard care for frozen shoulder including a steroid injection at the shoulder and referral to physical therapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of adhesive capsulitis of the shoulder
Key exclusion criteria (3 listed)
- History of hormone sensitive cancer
- Bilateral adhesive capsulitis of the shoulder
- Currently using hormonal treatments including contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Hormone Replacement Therapy plus standard care |
| Corticosteroid and 1%lidocainUltrasound-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. | Drug | Hormone Replacement Therapy plus standard care, Standard Care |
| physical therapyPatients 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. | Behavioural | Hormone Replacement Therapy plus standard care, Standard Care |
Primary outcome
American Shoulder and Elbow Surgeons (ASES) Shoulder Function Scores
Time frame: 6 months
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.
Shoulder range of motion via goniometry measures.
Time frame: 6 months
Investigators will assess the degree of flexion, extension, adduction, and abduction in the shoulder to determine range of motion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 26919573Klair 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.
- Background: PubMed 40375116Hamed-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.
- Background: PubMed 33205235Kraal 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.
- Background: PubMed 35097146Cogan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie E Wong, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hormone Replacement Therapy (HRT), Corticosteroid and 1%lidocain and physical therapy in people with Adhesive Capsulitis of the Shoulder and Frozen Shoulder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexa J Chandler, PhD ((415) 353-2808, alexa.chandler@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) Shoulder Function Scores (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07278323, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.