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Completed

NCT Number: NCT03547726

Physical Therapy After Reverse Total Shoulder Arthroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

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

Self-Rehab

Other

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 outcomes

  1. Forward Flexion Range of Motion 1

    Time frame: 3 months followup

    Active range of motion in the shoulder joint in forward flexion (measured in degrees)

Secondary outcomes

  1. Strength 1

    Time frame: 3 months followup

    Strength measured using a dynamometer

  2. Simple Shoulder Test Patient Reported Outcome 1

    Time frame: 3 months followup

    12 question questionnaire, scores are 0-12, 12 is best score (normal)

  3. Strength 2

    Time frame: 6 month followup

    Strength measured using a dynamometer

  4. Strength 3

    Time frame: 12 months followup

    Strength measured using a dynamometer

  5. Internal Rotation Range of Motion 1

    Time frame: 3 months followup

    Active range of motion in the shoulder joint in internal rotation (measured in degrees)

  6. External Rotation Range of Motion 1

    Time frame: 3 months followup

    Active range of motion in the shoulder joint in external rotation (measured in degrees)

  7. Internal Rotation Range of Motion 2

    Time frame: 6 month followup

    Active range of motion in the shoulder joint in internal rotation (measured in degrees)

  8. External Rotation Range of Motion 2

    Time frame: 6 month followup

    Active range of motion in the shoulder joint in external rotation (measured in degrees)

  9. Forward Flexion Range of Motion 2

    Time frame: 6 months followup

    Active range of motion in the shoulder joint in forward flexion (measured in degrees)

  10. Forward Flexion Range of Motion 3

    Time frame: 12 months followup

    Active range of motion in the shoulder joint in forward flexion (measured in degrees)

  11. Internal Rotation Range of Motion 2

    Time frame: 12 months followup

    Active range of motion in the shoulder joint in internal rotation (measured in degrees)

  12. External Rotation Range of Motion 2

    Time frame: 12 months followup

    Active range of motion in the shoulder joint in external rotation (measured in degrees)

  13. American Shoulder and Elbow Surgeons Shoulder Score 1

    Time frame: 3 month followup

    17 question questionnaire, normalized to a 0-100 scale, 100 is normal

  14. Simple Shoulder Test Patient Reported Outcome 2

    Time frame: 6 month followup

    12 question questionnaire, scores are 0-12, 12 is best score (normal)

  15. Simple Shoulder Test Patient Reported Outcome 3

    Time frame: 12 month followup

    12 question questionnaire, scores are 0-12, 12 is best score (normal)

  16. Single Assessment Numeric Evaluation (SANE) Score 1

    Time frame: 3 month followup

    1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder

  17. American Shoulder and Elbow Surgeons Shoulder Score 2

    Time frame: 6 month followup

    17 question questionnaire, normalized to a 0-100 scale, 100 is normal

  18. American Shoulder and Elbow Surgeons Shoulder Score 3

    Time frame: 12 month followup

    17 question questionnaire, normalized to a 0-100 scale, 100 is normal

  19. Single Assessment Numeric Evaluation (SANE) Score 2

    Time frame: 6 month followup

    1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder

  20. Single Assessment Numeric Evaluation (SANE) Score 3

    Time frame: 12 month followup

    1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 6, 2018
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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