Physical Therapy After Reverse Total Shoulder Arthroplasty

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547726
• Other study ID #: F11223344
• Status: Completed
• Phase: N/A
• Start date: February 27, 2019
• Est. completion date: January 19, 2022

Study information

• Verified date: January 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 19, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Other:
• Physical Therapy
These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
• 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.

Locations

Country	Name	City	State
United States	UAB Hospital Highlands	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

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