Hormone Replacement Therapy for Frozen Shoulder

(FSHRT Trial)

Overseen By Alexa J Chandler, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

I have been diagnosed with frozen shoulder.

Exclusion Criteria

I am currently using hormonal treatments or contraceptives.

I have had cancer that responds to hormone therapy.

I have frozen shoulder in both arms.

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?

Group I: Hormone Replacement Therapy plus standard care Experimental Treatment 3 Interventions

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.

Group II: Standard Care Active Control 2 Interventions

Participants will receive standard care for frozen shoulder including a steroid injection at the shoulder and referral to physical therapy

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+