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临床试验/NCT05358730
NCT05358730已完成不适用

Instrument-assisted Soft Tissue Mobilization to Exercise Programme Improves Outcomes in Patients with Adhesive Capsulitis

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2019年3月10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
2
主要终点
Upper extremity function

研究概览

简要总结

This study aimed to determine the effects of IASTM in combination with exercise in frozen shoulder. Thirty-five patients with phase II frozen shoulder included in this single-blind, randomized study. Patients were divided into two groups. In the first group exercise programme (Group 1) and in the second group IASTM in combination with exercise programme (Group 2) were applied for twelve sessions (two days per week for six week). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score and secondary outcomes were the visual analogue scale (VAS), the range of motion (ROM), The Constant score and Short- Form-36 (SF-36). Outcome measures were performed at baseline, after the 6th session and the 12th session.

详细描述

Instrument Assisted Soft Tissue Mobilization (IASTM) is a popular treatment for myofascial restriction based on the logic developed by James Cyriax. IASTM is applied using specially designed instruments to provide a mobilizing effect on soft tissue (eg scar tissue, myofascial adhesion) to reduce pain, improve joint range of motion and function. IASTM can help improve fibroblast proliferation and promote normal collagen sequencing, however, there is no enough study evaluating the results of IASTM use in patients with frozen shoulders in the literature. This study aimed to determine the effects of IASTM in combination with exercise in the treatment of frozen shoulder. Therefore, it was hypothesized that exercise programme combined with IASTM are more effective in improving pain, range of motion (ROM), and functionality than are the exercise programme alone.

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
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 30 and 65 years;
  • Duration of complaint of more than three months
  • ROM in external rotation, abduction and flexion less than 50% in comparison to uninvolved shoulder in one or more of three movement directions

排除标准

  • Having cervical radiculopathy
  • Thoracic outlet syndrome
  • Rheumatological disorders
  • Fractures or tumors of either upper extremity
  • Corticosteroid injections in the affected shoulder within the previous 4 weeks

结局指标

主要结局

Upper extremity function

时间窗: Baseline

DASH is a 30-item questionnaire that evaluates functionality, pain, emotional and social parameters in the upper extremity. Twenty-one questions evaluate patients' difficulties in daily life activities, 5 questions symptoms, 4 questions social function, work, sleep and self-confidence. For each question, the participant marks the option that suits patients in the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: inability). Score between 0 and 100 were obtained from each section.

次要结局

  • The severity of pain(At the end of the 6-week intervention)
  • Range of motion(At the end of the 6-week intervention)
  • Functional level of shoulder(At the end of the 6-week intervention)
  • Upper extremity function(At the end of the 6-week intervention)
  • Health-related quality of life(At the end of the 6-week intervention)

研究者

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

Tansu Birinci

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (2)

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