Early Mobilization Following Arthroscopic Rotator Cuff Repair
Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial
Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation.
This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups:
Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only.
Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery.
Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.
調査の概要
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
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Alberta
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Edmonton、Alberta、カナダ、T6G 2H9
- Glen Sather Sports Medicine clinic
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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:
- Patient is over 18 years of age
- Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
- Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
Exclusion Criteria:
- Patient has a full-thickness tear of the subscapularis and/or teres minor
- Patient has undergone previous RC surgery to the affected shoulder
- Patient has major joint trauma, infection, or avascular necrosis
- Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
- Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
- Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
- Patient has a major medical illness where life expectancy is less than 2 years
- Patient does not speak/read/understand English
- Patient has no fixed address or means of contact
- Surgeon or patient has decided to cancel surgery
- Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
- Patient unwilling to complete necessary follow-ups
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Group A (early ROM)
Group A (early ROM) will use the sling for comfort only
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Early range of motion
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アクティブコンパレータ：Group B (usual care)
Group B (usual care) will be immobilized in a sling for 6 weeks.
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Patients will use the sling for 6 weeks, as per usual care
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Western Ontario Rotator Cuff Index (WORC)
時間枠：Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire.
Measured in percentage.
0% = worst, 100 % = best
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Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Range of Motion (ROM)
時間枠：baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Measured flexion, abduction, external rotation in 90 degrees abduction [ER(90)], internal rotation in 90 degrees abduction [IR(90)], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout
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baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Strength
時間枠：Baseline, 6 months, 12 months, 24 months
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strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT).
Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion.
External and internal rotation were measured in 90 degrees of abduction.
Peak values were recorded during each contraction which was held for 3 seconds.
Values were expressed as raw values.
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Baseline, 6 months, 12 months, 24 months
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The Short Form (36) Health Survey
時間枠：baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health.
Each scale ranges between 0 (completely disable) to 100 (completely able).
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baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Adverse Events
時間枠：2 weeks, 6 weeks, 3 months, 6months
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The following complications were monitored throughout study:
The surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling). |
2 weeks, 6 weeks, 3 months, 6months
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Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
時間枠：baseline, 6 weeks, 3, 6, 12, 24 months
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Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)
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baseline, 6 weeks, 3, 6, 12, 24 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：David Sheps, MD,MSc,FRCSC、University of Alberta
研究記録日
主要日程の研究
研究開始
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
- RES0005824
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