Health TrialsbyHealthPanel

Frozen Shoulder and Hormone Replacement Therapy

ConditionsAdhesive Capsulitis of the ShoulderFrozen Shoulder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age40+
SponsorUniversity of California, San Francisco

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of adhesive capsulitis of the shoulder

Disqualifiers

History of hormone sensitive cancer

Bilateral adhesive capsulitis of the shoulder

Currently using hormonal treatments including contraceptives

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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%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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Hormone Replacement Therapy plus standard careExperimental treatment 3 interventions
Group B: Standard CareActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months

Secondary outcomes

Other outcomes

1

Shoulder Functional Workspace

Kinectigram by Bioniks will be used to evaluate the functional workspace of the shoulder. This motion capture system assesses the ability of participants to reach with their hands to determine the total area the hand can reach relative to the shoulder.

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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