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Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

Sponsor
Washington University School of Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03430167
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
59.1
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: home therapy
  • Other: formal therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
post operative assessor obtaining range of motion and performing physical exam will be blinded to participant's group.
Primary Purpose:
Treatment
Official Title:
Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial
Actual Study Start Date :
Jan 29, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
61 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Utah - Orthopedics Salt Lake City Utah United States 84108

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Aaron Chamberlain, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03430167
Other Study ID Numbers:
  • 201703024
First Posted:
Feb 12, 2018
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine
Reverse Total Shoulder Arthroplasty
post operative physical therapy
Additional relevant MeSH terms:
Joint Diseases

Study Results

No Results Posted as of Feb 14, 2022