Prospective Randomized Trial of Rotator Cuff Repair Postoperative Rehabilitation: Jackins' Exercises Versus Pulleys
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Western Ontario Rotator Cuff Index (WORC)
研究概览
简要总结
There are very few level 1 or level 2 evidence studies that examine postoperative rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of level 1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009) that found only four studies that examined rotator cuff repair rehabilitation.
The current study was performed to determine if there is a significant difference in passive glenohumeral joint range of motion, active glenohumeral joint range of motion, scapular substitution, and subjects measured outcome scores (clinimetrics) in patients who undergo rotator cuff repair when treated postoperatively with pulley exercises compared to Jackins' exercises.
Null Hypothesis: There will be no significant difference in passive range of motion, active range of motion, scapular substitution, and subject measured outcomes scores in subjects who undergo rotator cuff repair when treated with pulley exercises compared to Jackins' exercises.
详细描述
Scapulothoracic substitution for forward elevation is seen clinically when patients have shoulder pain. The patient uses the trapezius musculature to superiorly elevate the upper extremity instead of using the deltoid and the rotator cuff for upper extremity elevation. Scapulothoracic substitution does not occur in healthy shoulders. Excessive scapular movement can be due to an attempt to substitute for poorly functioning shoulder musculature or tightness of the capsular structures of the glenohumeral joint.
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength. Jackins described a series of exercises that are used to improve active range of motion and develop strength without the use of pulleys. The use of pulleys in the post-operative care for patients who have had shoulder surgery is thought to contribute to excessive scapular motion. To date, there has not been any study that compares the use of pulleys and Jackins' exercises with respect to active range of motion, scapulothoracic substitution, and objective patient outcomes measures. Due to the lack of level 1 or 2 evidence postoperative rehabilitation studies, a prospective randomized study should be performed on patients that have underwent rotator cuff repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing post-operative rehabilitation for a rotator cuff repair
排除标准
- •Patients who do not have permission from their treating surgeon to enroll in this study.
- •Patients who have undergone a previous rotator cuff repair on the non-operated side.
- •Patients who have undergone a previous rotator cuff repair on the ipsilateral shoulder.
- •Patients who have a history of adhesive capsulitis. Patients who are unwilling to participate in all aspects of the study. Patients who are cognitively impaired. Patients with known axillary or suprascapular neuropathy. Patients with a painful or dysfunctional contralateral shoulder.
研究组 & 干预措施
Postoperative Jackins Exercise Protocol
Jackin's exercises were initially designed for patients with difficulty performing forward elevation. The patient initially is positioned supine to perform shoulder flexion. When the patient can actively elevate in the supine position, one to two pounds of weight is placed in the patients hand and the patient is asked to repeat the maneuver of supine active elevation. When the patient can do this with little difficulty, the head of the bed is elevated approximately 20 degrees from the supine position and the sequence is repeated. Once the patient is able to perform flexion in this elevated head position, the inclination of the patient is increased in 20 degree increments until the patient is able to perform upright sitting shoulder flexion.
干预措施: Postoperative Jackins Exercise Protocol (Procedure)
Postoperative Pulleys Exercise Protocol
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength.
干预措施: Postoperative Pulleys Exercise Protocol (Procedure)
结局指标
主要结局
Change in Western Ontario Rotator Cuff Index (WORC)
时间窗: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
The WORC(ref 6) is a valid,reliable, and responsive patient-reported outcomes measures that assesses response to treatment for rotator cuff disease. A minimally important clinical difference (MCID) has been determined. Its use has been recommended in clinical trials.
次要结局
- Change in Simple Shoulder Test9(Baseline, 6 weeks, 12 weeks, 6 months, 1 year)
- Change in scapular substitution (centimeters)(Baseline, 6 weeks, 12 weeks, 6 months, 1 year)
- Change in range of motion (degrees)(Baseline, 6 weeks, 12 weeks, 6 months, 1 year)
- Change in strength (N)(Baseline, 6 weeks, 12 weeks, 6 months, 1 year)
- Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score(Baseline, 6 weeks, 12 weeks, 6 months, 1 year)
- Change in Marx Shoulder Activity Score2(Baseline, 6 weeks, 12 weeks, 6 months, 1 year)
- Change in Single Assessment Numeric Evaluation (SANE) rating(Baseline, 6 weeks, 12 weeks, 6 months, 1 year)
研究者
Keith Baumgarten
MD
Orthopedic Institute, Sioux Falls, SD