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临床试验/NCT03597490
NCT03597490终止不适用

Effectiveness of Multimodal Physical Therapy Combined With Exercise in Partial-thickness Rotator Cuff Tears: a Prospective Observational Study

Izmir Katip Celebi University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
1
主要终点
Pain/function

研究概览

简要总结

The aim of this study is to investigate the early stage effectiveness of multimodal physical therapy with exercise in the conservative treatment of partial thickness rotator cuff tears.

详细描述

Although partial thickness rotator cuff tear prevalence is greater than those of full-thickness tear, most studies on conservative treatment are associated with full-thickness tears. In general, any physical therapy modality alone is not effective in the treatment of rotator cuff tears. It has been reported that multimodal physiotherapy may be more successful than monotherapy, but evidence in this regard is inadequate. Therefore this observational prospective study aiming to investigate the effectiveness of physiotherapy in the treatment of rotator cuff tears was planned. The null hypothesis of this study is that multimodal physical therapy combined with exercise has no effect on pain and function in the treatment of partial thickness rotator cuff tears. The alternative hypothesis is the opposite.

Patients will be assessed by standardized measures in terms of pain and function (American Shoulder and Elbow Surgeons standardized shoulder form: patient self report section), active range of motion (goniometric measurement) and quality of life (Western Ontario rotator cuff index) at baseline and first, third and 6th months of follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Symptomatic partial thickness rotator cuff tear verified with magnetic resonance imaging or ultrasound imaging
  • Prescription of multimodal physical therapy with exercise by a clinician other than investigators prior to inclusion in the study
  • Covered by the social security system
  • Giving informed consent to include in the study

排除标准

  • Age of under 50
  • Full thickness rotator cuff tear
  • Radicular pain
  • Glenohumeral osteoarthritis
  • Calcific tendonitis
  • Adhesive capsulitis
  • History of physiotherapy in last 6 months
  • Prior surgical treatment
  • Contraindication to physical therapy and/or exercises

结局指标

主要结局

Pain/function

时间窗: Baseline to 6 months follow-up

Pain and function are assessed by Turkish version of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section. It consists of two subscales including pain (one item) and function section (ten items). Pain and function subscales range between 0 and 50 with a maximum total score of 100. Lower pain subscale score means more pain, and lower function subscale score means more functional loss. The Turkish version of ASES standardized shoulder form:patient self reported section has been reported as reliable and valid.

次要结局

  • Disease specific health-related quality of life(Baseline to 6 months follow-up)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ilker şengül

Principal Investigator

Izmir Katip Celebi University

研究点 (1)

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