Physical Therapy After Reverse Total Shoulder Arthroplasty

Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Other: Physical Therapy; Other: Self-Rehab

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Hospital Highlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical Therapy; This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.	Other: Physical Therapy; These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
Experimental: Self-Rehab; 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.	Other: Self-Rehab; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forward Flexion Range of Motion 1	Active range of motion in the shoulder joint in forward flexion (measured in degrees)	3 months followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength 1	Strength measured using a dynamometer	3 months followup
Simple Shoulder Test Patient Reported Outcome 1	12 question questionnaire, scores are 0-12, 12 is best score (normal)	3 months followup
Strength 2	Strength measured using a dynamometer	6 month followup
Strength 3	Strength measured using a dynamometer	12 months followup
Internal Rotation Range of Motion 1	Active range of motion in the shoulder joint in internal rotation (measured in degrees)	3 months followup
External Rotation Range of Motion 1	Active range of motion in the shoulder joint in external rotation (measured in degrees)	3 months followup
Internal Rotation Range of Motion 2	Active range of motion in the shoulder joint in internal rotation (measured in degrees)	6 month followup
External Rotation Range of Motion 2	Active range of motion in the shoulder joint in external rotation (measured in degrees)	6 month followup
Forward Flexion Range of Motion 2	Active range of motion in the shoulder joint in forward flexion (measured in degrees)	6 months followup
Forward Flexion Range of Motion 3	Active range of motion in the shoulder joint in forward flexion (measured in degrees)	12 months followup
Internal Rotation Range of Motion 2	Active range of motion in the shoulder joint in internal rotation (measured in degrees)	12 months followup
External Rotation Range of Motion 2	Active range of motion in the shoulder joint in external rotation (measured in degrees)	12 months followup
American Shoulder and Elbow Surgeons Shoulder Score 1	17 question questionnaire, normalized to a 0-100 scale, 100 is normal	3 month followup
Simple Shoulder Test Patient Reported Outcome 2	12 question questionnaire, scores are 0-12, 12 is best score (normal)	6 month followup
Simple Shoulder Test Patient Reported Outcome 3	12 question questionnaire, scores are 0-12, 12 is best score (normal)	12 month followup
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	3 month followup
American Shoulder and Elbow Surgeons Shoulder Score 2	17 question questionnaire, normalized to a 0-100 scale, 100 is normal	6 month followup
American Shoulder and Elbow Surgeons Shoulder Score 3	17 question questionnaire, normalized to a 0-100 scale, 100 is normal	12 month followup
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	6 month followup
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	12 month followup

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Amit M Momaya, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: F11223344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No