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临床试验/NCT05214547
NCT05214547招募中不适用

Focal Vibration Therapy Effectiveness in the Treatment of Patients With Adhesive Capsulitis

Bitlis Eren University2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2022年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Change from Baseline Shoulder Pain at 4 weeks

研究概览

简要总结

We hypothesize that focal vibration therapy will reduce pain, increase the mobilization of the glenohumeral joint, and will improve functionality in patients with adhesive capsulitis.

详细描述

The underlying mechanism of focal vibration therapy in individuals with adhesive capsulitis still remains unclear. Considering the physiological mechanism of focal vibration therapy, the effect of focal vibration therapy on pain, function, and resting muscle tone in patients with adhesive capsulitis will be evaluated. There are no studies examining the effect of focal vibration therapy on shoulder muscle tone in individuals with adhesive capsulitis.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged > 18 years
  • Unilateral adhesive capsulitis of the shoulder
  • The symptom duration > 3 months
  • Shoulder pain
  • The limited glenohumeral joint active range of motion of greater than 50% in at least three specific movements among abduction, flexion, internal rotation, and external rotation

排除标准

  • Previous shoulder surgeries
  • Massive, minor, and major rotator cuff tears
  • Pain and muscle strength loss due to neurological causes
  • History or presence of malignancy
  • Osteoporosis

结局指标

主要结局

Change from Baseline Shoulder Pain at 4 weeks

时间窗: At 4 week

Evaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" on the far left and "the most intense pain imaginable" on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.

Change from 4 weeks Shoulder Pain at 6 weeks

时间窗: At 6 week

Evaluation of shoulder pain was performed using the Visual Analog Scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" on the far left and "the most intense pain imaginable" on the far right.The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity. A higher score indicates greater pain intensity.

次要结局

  • Change from Baseline Range of Motion of Shoulder Joint at 4 weeks(At 4 weeks)
  • Change from 4 weeks Range of Motion of Shoulder Joint at 6 weeks(At 6 weeks)
  • Change from 4 weeks Shoulder Function at 6 weeks(At 6 weeks)
  • Change from Baseline Shoulder Function at 4 weeks(At 4 weeks)

研究者

发起方
Bitlis Eren University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tülay Çevik Saldıran

Associate Professor

Bitlis Eren University

研究点 (2)

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