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.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Copenhagen、デンマーク、2400
- Bispebjerg and Frederiksberg Hospitals
-
Copenhagen、デンマーク、2730
- Herlev and Gentofte Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Progressive early passive and active movement
Active exercise starts one week after surgery.
|
Post-surgical physical therapy including active exercise
|
|
アクティブコンパレータ：Limited early passive movement
Active exercise starts six weeks after surgery.
|
Post-surgical physical therapy including passive mobilisation
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
時間枠：12 weeks
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
時間枠：6 and 52 weeks
|
6 and 52 weeks
|
|
|
Change from baseline in Disability Arm Shoulder Hand (DASH)
時間枠：6, 12 and 52 weeks
|
6, 12 and 52 weeks
|
|
|
Global Rating Scale (GRS)
時間枠：6, 12 and 52 weeks
|
Global perceived treatment effect
|
6, 12 and 52 weeks
|
|
Change from baseline in Numeric Pain Rating Scale (NPRS)
時間枠：6, 12 and 52 weeks
|
6, 12 and 52 weeks
|
|
|
Change from baseline in Shoulder Range of Motion (ROM)
時間枠：6, 12 and 52 weeks
|
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
時間枠：12 and 52 weeks
|
Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.
|
12 and 52 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ultrasound imaging of rotator cuff tendons
時間枠：6 weeks
|
Assessment of possible re-ruptures of tendons
|
6 weeks
|
|
Ultrasound Imaging of rotator cuff tendons
時間枠：52 weeks
|
Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons
|
52 weeks
|
|
Return to work
時間枠：6 and 52 weeks
|
Patient-reported time (days) til return to full work capacity.
|
6 and 52 weeks
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FYS012
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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