Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

Not Applicable

Completed

• Conditions: Shoulder Arthropathy Associated With Other Conditions
• Interventions: Other: home therapy; Other: formal therapy

• Registration Number: NCT03430167
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-23
• Study Start: 2018-01-29
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II - Home Therapy	home therapy	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.
Group I - Formal Therapy	formal therapy	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.

Primary Outcome Measures

Name	Time	Method
Range of Motion Outcomes	Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively	Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome Scores - Quality of Life	Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively	Compare change in The Western Ontario Osteoarthritis Score (WOOS) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.; The WOOS includes 19 items (0-100 visual analog scale) which assess 1. pain and physical symptoms 2. sports, recreation, and work 3. lifestyle function, and 4. emotional function. A higher score represents a worse outcome.
Clinical Outcome Scores - Functional	Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively	Compare change in American Shoulder and Elbow Surgeons Score (ASES) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.; The ASES includes 1 pain item (0-100 visual analog scale) and 10 items which assess functional status (0=Unable to do, 1=Very difficult to do, 2=Somewhat difficult, 3=Not difficult). A higher score represents a better outcome.
Clinical Outcome Scores - Pain	Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively	Compare change in Visual Analogue Pain Score (0-100) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.

Trial Locations

Locations (1)

University of Utah - Orthopedics; 🇺🇸 Salt Lake City, Utah, United States