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Physical Therapy After Reverse Total Shoulder Arthroplasty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03547726
Enrollment
100
Registered
2018-06-06
Start date
2019-02-27
Completion date
2022-01-19
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Disorder

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.

Interventions

OTHERPhysical Therapy

These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.

OTHERSelf-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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Masking description

The physician will not know if the patient is receiving at home physical therapy or seeing a physical therapist in clinic.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Forward Flexion Range of Motion 13 months followupActive range of motion in the shoulder joint in forward flexion (measured in degrees)

Secondary

MeasureTime frameDescription
Simple Shoulder Test Patient Reported Outcome 13 months followup12 question questionnaire, scores are 0-12, 12 is best score (normal)
Strength 26 month followupStrength measured using a dynamometer
Strength 312 months followupStrength measured using a dynamometer
Internal Rotation Range of Motion 13 months followupActive range of motion in the shoulder joint in internal rotation (measured in degrees)
External Rotation Range of Motion 13 months followupActive range of motion in the shoulder joint in external rotation (measured in degrees)
Internal Rotation Range of Motion 26 month followupActive range of motion in the shoulder joint in internal rotation (measured in degrees)
External Rotation Range of Motion 26 month followupActive range of motion in the shoulder joint in external rotation (measured in degrees)
Forward Flexion Range of Motion 26 months followupActive range of motion in the shoulder joint in forward flexion (measured in degrees)
Strength 13 months followupStrength measured using a dynamometer
American Shoulder and Elbow Surgeons Shoulder Score 13 month followup17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Simple Shoulder Test Patient Reported Outcome 26 month followup12 question questionnaire, scores are 0-12, 12 is best score (normal)
Simple Shoulder Test Patient Reported Outcome 312 month followup12 question questionnaire, scores are 0-12, 12 is best score (normal)
Single Assessment Numeric Evaluation (SANE) Score 13 month followup1 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 26 month followup17 question questionnaire, normalized to a 0-100 scale, 100 is normal
American Shoulder and Elbow Surgeons Shoulder Score 312 month followup17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Single Assessment Numeric Evaluation (SANE) Score 26 month followup1 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 312 month followup1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
Forward Flexion Range of Motion 312 months followupActive range of motion in the shoulder joint in forward flexion (measured in degrees)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026