search
Back to results

Physical Therapy After Reverse Total Shoulder Arthroplasty

Primary Purpose

Orthopedic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
Self-Rehab
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patients who agree to receive a reverse total shoulder arthroplasty by one of our participating surgeons

Exclusion Criteria:

  • • Revision shoulder replacement surgery

    • Mentally incompetent to provide informed consent
    • Non-english speaking
    • Minors (<18)
    • Pregnant women
    • Prison population
    • Acute Shoulder Fractures

Sites / Locations

  • UAB Hospital Highlands

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Physical Therapy

Self-Rehab

Arm Description

This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.

This group of patients will be provided with a list of actions not to perform during the stages of their rehab (to avoid injury), and allowed to rehab their shoulder at their own pace.

Outcomes

Primary Outcome Measures

Forward Flexion Range of Motion 1
Active range of motion in the shoulder joint in forward flexion (measured in degrees)

Secondary Outcome Measures

Strength 1
Strength measured using a dynamometer
Simple Shoulder Test Patient Reported Outcome 1
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Strength 2
Strength measured using a dynamometer
Strength 3
Strength measured using a dynamometer
Internal Rotation Range of Motion 1
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
External Rotation Range of Motion 1
Active range of motion in the shoulder joint in external rotation (measured in degrees)
Internal Rotation Range of Motion 2
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
External Rotation Range of Motion 2
Active range of motion in the shoulder joint in external rotation (measured in degrees)
Forward Flexion Range of Motion 2
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
Forward Flexion Range of Motion 3
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
Internal Rotation Range of Motion 2
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
External Rotation Range of Motion 2
Active range of motion in the shoulder joint in external rotation (measured in degrees)
American Shoulder and Elbow Surgeons Shoulder Score 1
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Simple Shoulder Test Patient Reported Outcome 2
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Simple Shoulder Test Patient Reported Outcome 3
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Single Assessment Numeric Evaluation (SANE) Score 1
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
American Shoulder and Elbow Surgeons Shoulder Score 2
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
American Shoulder and Elbow Surgeons Shoulder Score 3
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Single Assessment Numeric Evaluation (SANE) Score 2
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
Single Assessment Numeric Evaluation (SANE) Score 3
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder

Full Information

First Posted
April 29, 2018
Last Updated
January 31, 2022
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT03547726
Brief Title
Physical Therapy After Reverse Total Shoulder Arthroplasty
Official Title
Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
January 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

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
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.
Detailed Description
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate. There is very limited orthopaedic literature focusing on the postoperative rehabilitation after reverse TSA. The majority of research is in the physical therapy literature focusing on the actual rehabilitation protocol. However, there has never been a large, randomized clinical trial that asks the question of whether or not physical therapy after reverse TSA is even necessary, or if patients will have comparable outcomes if they perform their own at home rehabilitation. There are surgeons nationwide that are on either end of the spectrum. Some encourage patients to see a therapist for a prolonged period of time with a set regimen of exercises, while others do not encourage any formal physical therapy and instead give patients a list of movements not to perform and allow them to recover at their own pace. We hypothesize that there will be comparable clinical outcomes between patients randomized to receive physical therapy versus an at home, self-led rehabilitation protocol. There are no deleterious effects of either treatment wing. Patients who agree to undergo reverse TSA after a preoperative appointment with their attending surgeon will be invited to participate in the study. They will complete the below mentioned survey instruments. They will receive their procedure and appropriate postoperative treatment. Patients will then be randomized to either the physical therapy or self-rehab group. Both groups will receive the standard postoperative physical therapy protocol. The only difference between the groups will be if a physical therapist sees the patients in their clinic, or if the patients self-rehabilitate with a list of limitations throughout their recovery course. The physical therapy protocol provided to the physical therapists and patients is attached. Clinical outcomes will be measured using the attached survey instruments: Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons Shoulder Score (ASES-SS), and the Single Assessment Numeric Evaluation score (SANE). These are commonly used, validated survey instruments in the setting of orthopaedic shoulder research. The physical exam component of the study will include range of motion testing (measuring the degrees of movement using a goniometer) and strength testing (measured using the dynamometer) in both shoulders. These survey instruments and measurements will be performed at 3, 6, and 12 month postoperative follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be two groups of patients randomized either to receive formal physical therapy in clinic or a self-led at home rehabilitation regimen.
Masking
Care ProviderInvestigator
Masking Description
The physician will not know if the patient is receiving at home physical therapy or seeing a physical therapist in clinic.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.
Arm Title
Self-Rehab
Arm Type
Experimental
Arm Description
This group of patients will be provided with a list of actions not to perform during the stages of their rehab (to avoid injury), and allowed to rehab their shoulder at their own pace.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
Intervention Type
Other
Intervention Name(s)
Self-Rehab
Intervention Description
These patients will be provided with a list of actions NOT to perform and allowed to self rehabilitate. They will not see a physical therapist.
Primary Outcome Measure Information:
Title
Forward Flexion Range of Motion 1
Description
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
Time Frame
3 months followup
Secondary Outcome Measure Information:
Title
Strength 1
Description
Strength measured using a dynamometer
Time Frame
3 months followup
Title
Simple Shoulder Test Patient Reported Outcome 1
Description
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Time Frame
3 months followup
Title
Strength 2
Description
Strength measured using a dynamometer
Time Frame
6 month followup
Title
Strength 3
Description
Strength measured using a dynamometer
Time Frame
12 months followup
Title
Internal Rotation Range of Motion 1
Description
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
Time Frame
3 months followup
Title
External Rotation Range of Motion 1
Description
Active range of motion in the shoulder joint in external rotation (measured in degrees)
Time Frame
3 months followup
Title
Internal Rotation Range of Motion 2
Description
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
Time Frame
6 month followup
Title
External Rotation Range of Motion 2
Description
Active range of motion in the shoulder joint in external rotation (measured in degrees)
Time Frame
6 month followup
Title
Forward Flexion Range of Motion 2
Description
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
Time Frame
6 months followup
Title
Forward Flexion Range of Motion 3
Description
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
Time Frame
12 months followup
Title
Internal Rotation Range of Motion 2
Description
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
Time Frame
12 months followup
Title
External Rotation Range of Motion 2
Description
Active range of motion in the shoulder joint in external rotation (measured in degrees)
Time Frame
12 months followup
Title
American Shoulder and Elbow Surgeons Shoulder Score 1
Description
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Time Frame
3 month followup
Title
Simple Shoulder Test Patient Reported Outcome 2
Description
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Time Frame
6 month followup
Title
Simple Shoulder Test Patient Reported Outcome 3
Description
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Time Frame
12 month followup
Title
Single Assessment Numeric Evaluation (SANE) Score 1
Description
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
Time Frame
3 month followup
Title
American Shoulder and Elbow Surgeons Shoulder Score 2
Description
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Time Frame
6 month followup
Title
American Shoulder and Elbow Surgeons Shoulder Score 3
Description
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Time Frame
12 month followup
Title
Single Assessment Numeric Evaluation (SANE) Score 2
Description
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
Time Frame
6 month followup
Title
Single Assessment Numeric Evaluation (SANE) Score 3
Description
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
Time Frame
12 month followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients who agree to receive a reverse total shoulder arthroplasty by one of our participating surgeons Exclusion Criteria: • Revision shoulder replacement surgery Mentally incompetent to provide informed consent Non-english speaking Minors (<18) Pregnant women Prison population Acute Shoulder Fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit M Momaya, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Hospital Highlands
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Physical Therapy After Reverse Total Shoulder Arthroplasty

We'll reach out to this number within 24 hrs