Evaluating Utilization Trends in Adhesive Capsulitis of the Shoulder: A Retrospective Cohort Analysis of a Large Database.
Charles J Cogan, Nicolas Cevallos, Ryan D Freshman...
https://pubmed.ncbi.nlm.nih.gov/35097146/Actively Recruiting
Led by University of California, San Francisco · Updated on 2026-06-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to evaluate the effects of hormone replacement therapy HRT combined with standard treatment on symptoms of frozen shoulder in women experiencing age-related menstrual changes such as perimenopause or menopause. Frozen shoulder, medically known as adhesive capsulitis, involves shoulder pain, stiffness, and reduced range of motion and mainly affects peri- and postmenopausal women. The study focuses on assessing the impact of adding HRT to standard care to improve shoulder function and reduce symptom severity. Participants will be randomly assigned to one of two groups one group will receive HRT consisting of a 0.5 mg estradiol skin patch and a daily 100 mg oral progestin pill for six months, along with standard care which includes a corticosteroid injection into the shoulder joint and physical therapy. The other group will receive only the standard care treatment. The steroid injections are guided by ultrasound and involve local anesthesia. Physical therapy includes referral and an at-home exercise program. During the study, participants will be monitored over six months with follow-up assessments including the American Shoulder and Elbow Surgeons ASES score and shoulder range of motion measurements to evaluate changes in pain, function, and movement. The study uses clinical measurements and a novel marker-less movement analysis system to assess functional workspace. Researchers will analyze changes within and between groups to understand the effects of HRT as an additional treatment. The total duration of participation is six months.
CONDITIONS
Frozen Shoulder and Hormone Replacement Therapy
A
Alexa J Chandler, PhD
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University of California, San Francisco
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Hormone Replacement Therapy (HRT) + Standard Care | Standard Care Only |
|---|---|---|
| What it is | Combination of hormone replacement therapy (estradiol skin patch and oral progestin) with corticosteroid and lidocaine joint injection, plus physical therapy. | Standard care with corticosteroid and lidocaine joint injection and a physical therapy/home exercise program. |
| Role in the trial | Acts as the experimental group to test if adding hormone therapy improves outcomes versus standard care alone. | Serves as the comparator group reflecting current typical management for frozen shoulder. |
| Primary use or purpose | To determine whether adding hormone replacement therapy to standard care improves shoulder function and range of motion in people with frozen shoulder. | To improve shoulder function and mobility using established injection therapy and rehabilitation exercises; represents current recommended management for frozen shoulder. |
| How it is given or performed | Participants use an estradiol skin patch (0.5mg) and take 100mg oral progestin daily for 6 months; receive a glenohumeral corticosteroid/lidocaine injection; and follow a physical therapy/exercise plan. | Participants receive an ultrasound-guided corticosteroid and lidocaine joint injection and are instructed in a home-based and therapist-assisted physical therapy program. |
| Evidence status | Efficacy and safety for frozen shoulder are not yet established; this study is ongoing and will determine whether adding HRT is beneficial. | Corticosteroid injection with physical therapy is supported by published evidence and is the most common management approach for adhesive capsulitis by musculoskeletal specialists. |
| Important limitations | Potential hormone-related risks in postmenopausal women and unknown benefits for adhesive capsulitis; mechanism for benefit in shoulder fibrosis is not established. Safety profile for this use is still under investigation. | Standard care may not fully resolve symptoms for all patients and can be associated with temporary increases in pain, potential injection complications, or incomplete recovery; some cases become chronic or recurrent despite treatment. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive hormone replacement therapy and standard care including a steroid injection and physical therapy, or standard care alone, for adhesive capsulitis of the shoulder.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/26919573/University of California, San Francisco
Lead Sponsor