Clinical Trials Directory

Trials / Completed

CompletedNCT03430167

Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
61 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial.

Detailed description

All patients who are evaluated by one of three Shoulder/Elbow Fellowship-trained surgeons at Washington University Department of Orthopedic Surgery and who meet the inclusion criteria will be offered enrollment in the study. Following consent the participant will be asked to undergo an exam of the shoulder and complete questionnaires related to shoulder pain and function. Demographic information, health history related to the affected shoulder, and co-morbidity data will also be collected preoperatively. Patients will be randomized to either a simple, standardized home exercise program or a supervised physiotherapy program administered by a physical therapist after undergoing a standardized operative protocol for reverse total shoulder arthroplasty. Post-operative range of motion will be measured in a blinded fashion at 6 weeks, 3 months, 6 months, and 12 months. A blinded observer will simultaneously measure validated functional outcomes scores including the Western Ontario Osteoarthritis Score, American Shoulder and Elbow Surgeons Score and Visual Analogue Score for pain pre-operatively and at 6 weeks, 3 months, 6 months, and 12 months post-operatively.

Conditions

Interventions

TypeNameDescription
OTHERhome therapyPatients will be given a set of instructions for completing home therapy for range of motion and strengthening
OTHERformal therapyPatients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises

Timeline

Start date
2018-01-29
Primary completion
2023-01-12
Completion
2023-01-12
First posted
2018-02-12
Last updated
2023-03-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03430167. Inclusion in this directory is not an endorsement.