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Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

Primary Purpose

Shoulder Arthropathy Associated With Other Conditions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
home therapy
formal therapy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Arthropathy Associated With Other Conditions focused on measuring Reverse Total Shoulder Arthroplasty, post operative physical therapy

Eligibility Criteria

61 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Utah - Orthopedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group I - Formal Therapy

Group II - Home Therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Outcome Scores - Quality of Life
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
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
Compare change in Visual Analogue Pain Score (0-100) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.

Full Information

First Posted
January 23, 2018
Last Updated
March 22, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03430167
Brief Title
Reverse Shoulder Replacement: Formal vs. Home Physiotherapy
Official Title
Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
January 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthropathy Associated With Other Conditions
Keywords
Reverse Total Shoulder Arthroplasty, post operative physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
post operative assessor obtaining range of motion and performing physical exam will be blinded to participant's group.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I - Formal Therapy
Arm Type
Other
Arm 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.
Arm Title
Group II - Home Therapy
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
home therapy
Intervention Description
Patients will be given a set of instructions for completing home therapy for range of motion and strengthening
Intervention Type
Other
Intervention Name(s)
formal therapy
Intervention Description
Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises
Primary Outcome Measure Information:
Title
Range of Motion Outcomes
Description
Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
Time Frame
Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Secondary Outcome Measure Information:
Title
Clinical Outcome Scores - Quality of Life
Description
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.
Time Frame
Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Title
Clinical Outcome Scores - Functional
Description
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.
Time Frame
Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively
Title
Clinical Outcome Scores - Pain
Description
Compare change in Visual Analogue Pain Score (0-100) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
Time Frame
Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear. A pre-operative plan for RTSA Age >60 Exclusion Criteria: Active infection Incompetent deltoid muscle Unwillingness or inability to participate in a home exercise program Medically unfit for operative intervention Revision RTSA RTSA for glenohumeral osteoarthritis or proximal humerus fracture Unwillingness to participate in the study Inability to read or comprehend written instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Chamberlain, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah - Orthopedics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

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