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Reverse Shoulder Replacement: Formal vs. Home Physiotherapy

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ClinicalTrials.gov Identifier: NCT03430167
Recruitment Status : Enrolling by invitation
First Posted : February 12, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Shoulder Arthropathy Associated With Other Conditions Other: home therapy Other: formal therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 : January 29, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



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Ages Eligible for Study:   61 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430167


Locations
United States, Utah
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

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03430167     History of Changes
Other Study ID Numbers: 201703024
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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
Musculoskeletal Diseases