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临床试验/NCT04552925
NCT04552925已完成不适用

The Effectiveness of Exercises with Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears: a Randomized Controlled Study

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Deltoid Strength

研究概览

简要总结

There are very few studies in the literature about conservative treatment of massive rotator cuff (RC) tears. Whether the treatment of massive RC tears is conservative or surgical is decided according to the age, activity level, expectation and additional pathologies of the patient. The aim of conservative treatment is to make the patient functionally independent and to reduce pain. In recent years, there are different opinions in the literature about the effectiveness of conservative treatment of massive RC tears. However, in recent biomechanical studies, it has been reported that the RC and the deltoid, which remain intact in massive RC tears, can function well together.

The hypothesis of this study is that the deltoid-focused physiotherapy program, where strengthening exercises are performed with EMG biofeedback, will give more positive results in terms of range of motion (ROM), functional status, muscle strength, pain and patients satisfaction. aim of our study is to investigate the efficacy of electromyographic biofeedback (EMG-BF) device which was added to deltoid focused conservative treatment program in massive RC 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral, non-traumatic massive rotator cuff tears according to Deorio and Cofield classification
  • Age older than 50 years and attend 1-year follow-up assessment

排除标准

  • Patients with symptomatic lesions in the contralateral shoulder
  • Cuff tear arthropathy
  • Glenohumeral osteoarthritis
  • Pseudoparalytic shoulder
  • Grade 3-4 fatty degeneration according to Goutallier classification
  • History of involved shoulder surgery
  • Major systemic conditions that disallowing exercise

结局指标

主要结局

Deltoid Strength

时间窗: 12 months

Measurement of the strength of the deltoid muscle with a digital dynamometer.

American shoulder and elbow (ASES) score

时间窗: 12 months

The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) is a standard shoulder assessment form, which is comprised of objective and subjective sections and prepared by shoulder and elbow surgeons.

次要结局

  • Numeric Pain Rating Scale (NPRS)(12 months)
  • Global rating of change scale (GRCS)(12 months)
  • Range of Motion (ROM)(12 months)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pelin Tiryaki

Lecturer

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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