CompletedNot Applicable

Home Exercise vs PT for Reverse Total Shoulder Arthroplasty

United States100 participantsStarted 2019-01-22

Plain-language summary

The primary objective of this study is to compare outcomes between formal clinic based physical therapy (PT) rehabilitation and surgeon directed home therapy (HT) after reverse total shoulder arthroplasty (RSA) as measured by pain, range of motion, Single Assessment Numerical Evaluation (SANE), and American Shoulder and Elbow Surgery (ASES) scores at 6 weeks, 3, 6, 12, and 24 months postoperatively. The secondary objective of this study is to determine if PT rehabilitation following RSA is associated with a higher level of postoperative complications, specifically acromial stress fractures or dislocation. This information will be useful to discern if PT is effective in providing pain relief more quickly, as well as improved motion and self-reported functional outcomes following RSA, which can assist surgeons and rehabilitation specialists in designing optimal care plans for this patient population. The project will also help to clarify if PT services place patients who have RSA at higher risk for acromial stress fractures or dislocation.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects who have RSA for cuff tear arthropathy, massive irreparable rotator cuff tear with pseudoparalysis, or primary osteoarthritis. Exclusion Criteria: * Subjects who have a non-reverse total shoulder arthroplasty, RSA for fracture, tendon transfers as part of RSA, and revision RSA * Subjects who had RSA and require discharge to skilled nursing facility, in-patient rehabilitation placement, or use of home health therapy prior to progressing in recovery * Subjects who cannot speak, read, or write the English language * Subjects who have cognitive deficits limiting ability to follow directions * Subjects who have inability to attend physical therapy (i.e. transportation or financial limitations)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Pain: Numerical Rating Scale

Timeframe: up to 2 years postoperatively

Range of motion

Timeframe: up to two years postoperatively

Patient-reported functional outcome- American Shoulder and Elbow Surgeons Score

Timeframe: up to two years postoperatively

Patient-reported functional outcome- Single Assessment Numeric Evaluation score

Timeframe: up to two years postoperatively

Trial details

NCT IDNCT03719859

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-11

View on ClinicalTrials.gov More Shoulder Arthritis trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Postoperative Pain: Numerical Rating Scale

Timeframe: up to 2 years postoperatively

Range of motion

Timeframe: up to two years postoperatively

Patient-reported functional outcome- American Shoulder and Elbow Surgeons Score

Timeframe: up to two years postoperatively

Patient-reported functional outcome- Single Assessment Numeric Evaluation score

Timeframe: up to two years postoperatively