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临床试验/NCT03929276
NCT03929276已完成不适用

Efficacy of High-intensity Laser Therapy in Patients With Adhesive Capsulitis

Hitit University2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年4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
31
试验地点
2
主要终点
Visual analogue scale for pain (VAS- pain)

研究概览

简要总结

Adhesive capsulitis is an idiopathic disease characterized by a decrease in the volume of the glenoid capsule, the development of fibrosis and a progressive decrease in the range of joint movement with pain. Shoulder pain and stiffness are accompanied by disability. The purpose of the study is to evaluate and compare the effects of high-intensity laser therapy on pain, disease - related disability and quality of life in patients with shoulder restriction and pain due to adhesive capsulitis.

详细描述

Adhesive capsulitis is an idiopathic disease characterized by a decrease in the volume of the glenoid capsule, the development of fibrosis and a progressive decrease in the range of joint movement with pain. Shoulder pain and stiffness are accompanied by disability. It is thought that the incidence is 3% to 5% in the general population and 20% in people with diabetes. Although usually reported to be self-limiting in 2 to 3 years, studies have reported that 40% of patients have persistent pain and stiffness for more than 3 years.

Therefore, various therapies are used to reduce pain and increase the range of motion more rapidly without waiting for spontaneous recovery. Adhesive capsulitis treatment includes conservative and surgical treatment options. The options for non-surgical treatments are pharmacological treatments including intra-articular injection and physical therapy modalities. As for physical therapy modalities, various interventions are used. These include heat or ice, therapeutic ultrasound, transcutaneous electrical nerve stimulation and laser therapies.

The aim of exercise programs consisting of joint range of motion (ROM), strengthening and stretching exercises, proprioceptive neuromuscular facilitation and mobilization techniques is to alleviate pain caused by the capsular contracture and to improve glenohumeral ROM.

The purpose of the study is to evaluate and compare the effects of high-intensity laser therapy on pain, disease - related disability and quality of life in patients with shoulder restriction and pain due to 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, Investigator)

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

入选标准

  • Subjects with adhesive capsulitis diagnosis by physical examination (Compared with intact side, there is more than 25% limitation in at least two directions of shoulder range of motion)
  • Subjects have complaints for at least 1 month
  • No pregnancy / breastfeeding

排除标准

  • History of bilateral adhesive capsulitis
  • History of shoulder trauma, fracture, shoulder shoulder surgery, calcific tendinopathy, glenohumeral osteoarthritis, inflammatory rheumatic diseases, tumor, infection
  • History of corticosteroid injection in the shoulder during the last 3 months
  • History of recent lung, breast or bypass surgery
  • History of cervical radiculopathy / brachial plexus lesion
  • History of neuromuscular disease
  • History of physical therapy program for the same shoulder in the last 6 months

结局指标

主要结局

Visual analogue scale for pain (VAS- pain)

时间窗: 2 weeks

Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

次要结局

  • Short Form Health Survey 36 (SF-36)(2 weeks)
  • Shoulder pain and disability index(2 weeks)
  • Range of motion of shoulder joint measurements(2 weeks)

研究者

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

Tuğba Atan

Assoc. Prof.

Hitit University

研究点 (2)

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