Effects of Slow and Accelerated Rehabilitation Protocols After Latissimus Dorsi Transfer in Massive, Irreparable Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Western Ontario Rotator Cuff Index
研究概览
简要总结
Latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.
详细描述
A variety of surgical options are proposed in the treatment of massive cuff tears. The treatment options include acromioplasty and tuberoplasty, partial repair with or without soft tissue augmentation, latissimus dorsi transfer (LDT), superior capsular reconstruction (SCR), and reverse total shoulder arthroplasty. Among these options, LDT is a well-recognized technique that aims to rebalance the soft tissue tension around the shoulder joint in order to prevent superior escape of the humeral head and loss of function. From a biomechanical standpoint, the transferred tendon is theorized to function as a humeral head depressor by means of a tenodesis effect, as well as by increasing the active external rotation through the transfer vector. It is an established treatment option with favorable results, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.
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 (Outcomes Assessor)
盲法说明
blinded assessor
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being in the age range of 18-65 years
- •being diagnosed with massive, irreparable rotator cuff tears based on magnetic resonance imaging and clinical continuity tests
- •symptoms are unresponsive to conservative care including steroid injections and physiotherapy for at least 6 months
- •having a good command of the Turkish language
- •scoring above 24 in the Mini Mental State Test
- •≥80% compliance in completing the post-ARCR Phase 1 trainings
- •volunteering to participate in the study
排除标准
- •diabetes mellitus
- •neurological problems
- •cervical disc herniation
- •visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.)
- •systemic inflammatory problems
- •hypermobility, trauma, and/or inflammation that could be a contraindication for mobilization
- •former shoulder fractures on the affected side
- •advanced glenohumeral arthritis (Hamada grade 3),
- •deltoid muscle dysfunction,
- •irreparable subscapularis tears,
- •active infection,
- •shoulder stiffness,
- •a history of previous shoulder surgery
结局指标
主要结局
Western Ontario Rotator Cuff Index
时间窗: 14 weeks
It has 21 items in four domains, including physical symptoms (ten questions), sports/recreation/work (four questions), lifestyle (four questions) and emotions (three questions). Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life due to pathological condition of the rotator cuff. Mathematic conversion yields a percentage score; higher percentages indicate proximity to normal function.
The Disabilities of the Arm, Shoulder and Hand Questionnaire
时间窗: 14 weeks
The Disabilities of the Arm, Shoulder and Hand Questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. It consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Constant-Murley Shoulder Score
时间窗: 14 weeks
Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. In the original publication, the pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points.
Visual analog scale
时间窗: 14 weeks
Visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
American Shoulder and Elbow Surgeons score
时间窗: 14 weeks
It is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Patients can complete the questionnaire in less than five minutes. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
次要结局
- Catastrophizing(14 weeks)
- Hospital Anxiety and Depression Scale(14 weeks)
- Tampa-Scale of Kinesiophobia(14 weeks)
- 12-Item Short-Form Health Survey(14 weeks)
研究者
Caner Karartı
Principal Investigator
Hacettepe University