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Physical Therapy After Reverse Total Shoulder Arthroplasty

2022년 1월 31일 업데이트: Amit Momaya, University of Alabama at Birmingham

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Alabama
      • Birmingham, Alabama, 미국, 35205
        • UAB Hospital Highlands

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Physical Therapy
This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.
These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
실험적: 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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Forward Flexion Range of Motion 1
기간: 3 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
3 months followup

2차 결과 측정

결과 측정
측정값 설명
기간
Strength 1
기간: 3 months followup
Strength measured using a dynamometer
3 months followup
Simple Shoulder Test Patient Reported Outcome 1
기간: 3 months followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
3 months followup
Strength 2
기간: 6 month followup
Strength measured using a dynamometer
6 month followup
Strength 3
기간: 12 months followup
Strength measured using a dynamometer
12 months followup
Internal Rotation Range of Motion 1
기간: 3 months followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
3 months followup
External Rotation Range of Motion 1
기간: 3 months followup
Active range of motion in the shoulder joint in external rotation (measured in degrees)
3 months followup
Internal Rotation Range of Motion 2
기간: 6 month followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
6 month followup
External Rotation Range of Motion 2
기간: 6 month followup
Active range of motion in the shoulder joint in external rotation (measured in degrees)
6 month followup
Forward Flexion Range of Motion 2
기간: 6 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
6 months followup
Forward Flexion Range of Motion 3
기간: 12 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
12 months followup
Internal Rotation Range of Motion 2
기간: 12 months followup
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
12 months followup
External Rotation Range of Motion 2
기간: 12 months followup
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
기간: 3 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
3 month followup
Simple Shoulder Test Patient Reported Outcome 2
기간: 6 month followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
6 month followup
Simple Shoulder Test Patient Reported Outcome 3
기간: 12 month followup
12 question questionnaire, scores are 0-12, 12 is best score (normal)
12 month followup
Single Assessment Numeric Evaluation (SANE) Score 1
기간: 3 month followup
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
기간: 6 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
6 month followup
American Shoulder and Elbow Surgeons Shoulder Score 3
기간: 12 month followup
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
12 month followup
Single Assessment Numeric Evaluation (SANE) Score 2
기간: 6 month followup
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
기간: 12 month followup
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
12 month followup

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Amit M Momaya, MD, University of Alabama at Birmingham

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 2월 27일

기본 완료 (실제)

2022년 1월 18일

연구 완료 (실제)

2022년 1월 19일

연구 등록 날짜

최초 제출

2018년 4월 29일

QC 기준을 충족하는 최초 제출

2018년 6월 4일

처음 게시됨 (실제)

2018년 6월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 2월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 1월 31일

마지막으로 확인됨

2022년 1월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • F11223344

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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