Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

The Washington University

Status: Completed

Conditions: Shoulder Arthropathy Associated With Other Conditions

Treatments: Other: formal therapy; Other: home therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03430167

201703024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 61+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear.
2. A pre-operative plan for RTSA
3. Age >60

Exclusion criteria

1. Active infection
2. Incompetent deltoid muscle
3. Unwillingness or inability to participate in a home exercise program
4. Medically unfit for operative intervention
5. Revision RTSA
6. RTSA for glenohumeral osteoarthritis or proximal humerus fracture
7. Unwillingness to participate in the study
8. Inability to read or comprehend written instructions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Group I - Formal Therapy

Other group

Description:

Supervised physical therapy will be ordered 2 times/week initially for 6 weeks and then tailored to a minimum of 1 visit/week based upon the individual progress of each patient. Home exercises will be provided to the patient by the therapist to be performed daily. Supervised physical therapy will be discontinued once the patient demonstrates independence with the final phase of rehabilitation, which represents the graduated strengthening program.

Treatment:

Other: formal therapy

Group II - Home Therapy

Other group

Description:

In the study group all patients will be instructed in a standardized fashion regarding a home exercise program. This program will involve a standardized a set of five exercises. These exercises will be reviewed with patients in clinic in a standardized fashion and patients will be provided with an instructive hand-out.

Treatment:

Other: home therapy