Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

ID: NCT03430167
Status: Enrolling by invitation
Phase: N/A
Start Date: January 29, 2018
First Submitted: January 23, 2018
Last Updated: February 14, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Shoulder Arthropathy Associated With Other Conditions
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Study Description

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.
Condition or disease Intervention/treatment Phase

Shoulder Arthropathy Associated With Other Conditions

Other: home therapy
Other Names
Other: formal therapy
Other Names
N/A

Tracking Information

First Submitted DateJanuary 23, 2018
Last Update Posted DateFebruary 14, 2018
Actual Start DateJanuary 29, 2018
Anticipated Completion DateOctober 01, 2023
Actual Primary Completion DateOctober 01, 2022
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Range of Motion Outcomes [Time Frame: Baseline and at 6 weeks, 3 months, and 12 months post-operatively]

    Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Clinical Outcome Scores - Quality of Life [Time Frame: Baseline and at 6 weeks, 3 months, and 12 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 [Time Frame: Baseline and at 6 weeks, 3 months, and 12 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 [Time Frame: Baseline and at 6 weeks, 3 months, and 12 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleReverse Shoulder Replacement: Formal vs. Home Physiotherapy
Official TitleSupervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial
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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
75
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Shoulder Arthropathy Associated With Other Conditions
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: home therapy

Patients will be given a set of instructions for completing home therapy for range of motion and strengthening

Other Names
Other: formal therapy

Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises

Other Names
Study Groups/Cohorts
Group I - 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.

Group II - 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.

Study Arms
Other Group I - 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.
Other : formal therapy
Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises

Other Group II - 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.
Other : home therapy
Patients will be given a set of instructions for completing home therapy for range of motion and strengthening

Arm Intervention/Treatment
Other Group I - 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.
Other : formal therapy
Other Group II - 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.
Other : home therapy

Recruitment Information

Recruitment Status:Enrolling by invitation
Enrollment75
Completion DateOctober 01, 2023
Eligibility Criteria: 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
GenderAll
Age61 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03430167
Other Study ID Numbers
201703024
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyAaron Chamberlain, Washington University School of Medicine
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Aaron Chamberlain, MD
Washington University School of Medicine

Publications