CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Physical Therapy +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03719859
NCT03719859N/ACompleted

Multicenter Randomized Trial of Home vs. Physical Therapist-Directed Rehabilitation for Reverse Total Shoulder Arthroplasty

Rush University Medical Center·interventional·Posted Oct 25, 2018·Updated Dec 22, 2025

In Brief

A clinical study evaluating Physical Therapy and Home Therapy for Shoulder Arthritis and Rotator Cuff Tear Arthropathy. Completed, enrolled 100 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 25, 2018
Enrollment StartJan 22, 2019
Primary CompletionAug 11, 2025
Study CompletionDec 12, 2025
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 7.7 years ago

Interventions

Physical Therapyother

Subjects who will participate in the physical therapy intervention group will attend therapy 4-6 days after discharge from the hospital, and continue in therapy approximately once a week for three months. The physical therapy progression will follow the standard of care developed at Duke Sports Medicine Physical Therapy for rehabilitation following RSA. Some of the patients in the PT intervention cohort may have physical therapy at an institution outside of Midwest Orthopaedics at Rush. All patients, whether in the Rush system or outside, will be given a prescription with the identical instructions for "physical therapy, status post (R/L) reverse total shoulder arthroplasty, 1-2 x per week x 12 weeks."

Home Therapyother

The surgeon/Nurse Practitioner/Physician Assistant will advance rehabilitation exercises and activity guidelines at customary scheduled postoperative appointments for this surgical procedure: 2 weeks (+/- 5 days), 6 weeks (+/- 1 week), 3 months and 6 months (+/- 1 month), and 1 and 2 years (+/- 2 months).