Progressive Active Exercise After Surgical Rotator Cuff Repair
Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up
Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. The National Patient Register in Denmark has registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.
A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of function due to pain and tissue weakness. Little is known about the effects of the postoperative training/rehabilitation, and this provides an unclear picture of the total treatment procedure of this condition.
The Danish National Clinical Guidelines from 2013 recommend that these patients are offered rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for postoperative training is moderate- low. The past few years, there have been conducted 5 systematic reviews looking at different rehabilitation parameters after rotator cuff surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon healing or clinical outcome. They also conclude that there is a further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load in high-quality, adequately powered trials, also considering key outcomes such as return to work.
Therefore, the aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.
Shortterm effects of physical function, pain, and quality of life will be studied as primary patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes in addition to the longterm effects of physical function, pain, and quality of life.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2400
- Bispebjerg and Frederiksberg Hospitals
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Copenhagen, 덴마크, 2730
- Herlev and Gentofte Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women and men above 18 years
- Operated due to traumatic full thickness RC-tear
- Involving supraspinatus (full thickness and width)
- Present with reduced arm elevation strength and pain
- Clinical diagnosis verified by arthroscopy
- Fully repairable RC-tear
Exclusion Criteria:
- Patients with non-traumatic RC-tears of the shoulder
- Patients with isolated teres minor or subscapularis tear
- Patients with partial thickness/ width tear
- Prior shoulder surgery (all shoulder joints)
- Glenohumeral osteo arthrosis (OA), rheumatoid arthritis or periarthrosis
- Inability to speak or read Danish
- Inability to perform and maintain the physical training
- Other condition negatively influencing compliance or conditions that in the opinion of the investigator puts a potential participant at increased risk or otherwise makes him/her unsuitable for participation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Progressive early passive and active movement
Active exercise starts one week after surgery.
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Post-surgical physical therapy including active exercise
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활성 비교기: Limited early passive movement
Active exercise starts six weeks after surgery.
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Post-surgical physical therapy including passive mobilisation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from baseline in Western Ontario Rotator Cuff Index (WORC)
기간: 12 weeks
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in Western Ontario Rotator Cuff Index (WORC)
기간: 6 and 52 weeks
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6 and 52 weeks
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Change from baseline in Disability Arm Shoulder Hand (DASH)
기간: 6, 12 and 52 weeks
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6, 12 and 52 weeks
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Global Rating Scale (GRS)
기간: 6, 12 and 52 weeks
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Global perceived treatment effect
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6, 12 and 52 weeks
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Change from baseline in Numeric Pain Rating Scale (NPRS)
기간: 6, 12 and 52 weeks
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6, 12 and 52 weeks
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Change from baseline in Shoulder Range of Motion (ROM)
기간: 6, 12 and 52 weeks
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6, 12 and 52 weeks
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Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption
기간: 12 and 52 weeks
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Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.
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12 and 52 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ultrasound imaging of rotator cuff tendons
기간: 6 weeks
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Assessment of possible re-ruptures of tendons
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6 weeks
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Ultrasound Imaging of rotator cuff tendons
기간: 52 weeks
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Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons
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52 weeks
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Return to work
기간: 6 and 52 weeks
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Patient-reported time (days) til return to full work capacity.
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6 and 52 weeks
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
- Kjaer BH, Magnusson SP, Warming S, Henriksen M, Krogsgaard MR, Juul-Kristensen B. Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial). Trials. 2018 Sep 3;19(1):470. doi: 10.1186/s13063-018-2839-5.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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