Hormone Replacement Therapy for Frozen Shoulder
(FSHRT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how hormone replacement therapy (HRT) affects frozen shoulder symptoms in women experiencing menopause-related changes, such as hot flashes or night sweats. Frozen shoulder causes pain and stiffness, making shoulder movement difficult. The study compares standard care alone to standard care with added HRT, which includes a hormone patch and a daily pill. Women diagnosed with frozen shoulder and experiencing menopause symptoms might be suitable candidates for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants the opportunity to benefit from established therapies.
Do I need to stop my current medications to join the trial?
The trial requires that you are not currently using hormonal treatments, including contraceptives, to participate.
What is the safety track record for hormone replacement therapy and corticosteroids?
Research has shown that hormone replacement therapy (HRT) is usually well-tolerated by women after menopause. Studies have found that women using HRT had a lower risk of developing painful shoulder problems compared to those who did not use it. This suggests that HRT might safely help with frozen shoulder symptoms in menopausal women.
While HRT works well for some, it's important to be aware of possible side effects, such as nausea, headaches, and mood changes. These side effects are often mild and manageable. Prospective clinical trial participants should discuss any concerns with their doctor.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard care for frozen shoulder, which typically involves steroid injections and physical therapy, the addition of Hormone Replacement Therapy (HRT) offers a new approach. Researchers are excited about this treatment because it incorporates an estrogen patch and oral progestin, which may help address hormonal imbalances that could contribute to the condition. This hormonal angle is unique, as most current treatments don't focus on hormonal factors, potentially offering a novel path to relief and improved outcomes for patients.
What evidence suggests that hormone replacement therapy might be an effective treatment for frozen shoulder?
Research has shown that hormone replacement therapy (HRT) might help with frozen shoulder. Studies have found that post-menopausal women using HRT have a lower chance of developing frozen shoulder, also known as adhesive capsulitis. Specifically, one study discovered that women on HRT were about half as likely to develop frozen shoulder compared to those not using HRT. This trial will evaluate HRT as part of one treatment arm, where participants will receive HRT in addition to standard care, which includes a steroid injection and physical therapy. This suggests that HRT could help reduce symptoms like pain and stiffness in the shoulder. The treatment involves using female hormones, which may be helpful during menopause-related changes.12356
Who Is on the Research Team?
Stephanie E Wong, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for women experiencing shoulder pain and stiffness, known as frozen shoulder, who are also going through perimenopause or menopause. Participants should be dealing with symptoms like hot flashes or night sweats. They must not have other conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either hormone replacement therapy plus standard care or only standard care for frozen shoulder
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Corticosteroid
- Hormone Replacement Therapy (HRT)
Trial Overview
The study aims to see if adding hormone replacement therapy (HRT), using a skin patch and oral pill, to standard care helps improve symptoms of frozen shoulder in women undergoing menopausal changes compared to standard care alone.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Participants will receive standard care for frozen shoulder including a steroid injection at the shoulder and referral to physical therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Citations
Frozen Shoulder and Hormone Replacement Therapy
The purpose of this study is to determine the effects of hormone replacement therapy (HRT) in addition to standard treatment on frozen ...
Poster 188: Is Hormone Replacing Therapy Associated ...
The purpose of this study was to determine if hormone replacing therapy (HRT) is protective against adhesive capsulitis in menopausal women.
3.
ortho.duke.edu
ortho.duke.edu/blog/jocelyn-wittstein-study-connects-estrogen-and-frozen-shoulder-menopausal-womenJocelyn Wittstein Study Connects Estrogen and Frozen ...
According to a study led by Duke Health researchers, post-menopausal women on hormone replacement therapy had a lower risk of developing a painful shoulder ...
4.
corporate.dukehealth.org
corporate.dukehealth.org/news/hormone-therapy-appears-reduce-risk-shoulder-pain-older-womenHormone Therapy Appears to Reduce Risk of Shoulder ...
Post-menopausal women on hormone replacement therapy had a lower risk of developing a painful shoulder condition known as adhesive capsulitis.
Frozen Shoulder in Perimenopause & Menopause
A 2023 Duke University study found that women using HRT were about half as likely to have frozen shoulder compared to those not on hormone ...
Frozen shoulder is real. Here's how it affects you during ...
And those who didn't use hormone therapy had 99 percent greater odds of receiving a frozen shoulder diagnosis than their counterparts who did.
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