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临床试验/NCT05335785
NCT05335785Unknown不适用

Efficacy of High Intensity Lazer Therapy in Patients Diagnosed With Partial Supraspinatus Tear

Izmir Katip Celebi University2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2020年12月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
VAS (visuel analog score)

研究概览

简要总结

Rotatorcuff lesions constitute 10% of the causes of shoulder pain. Supraspinatus tear is one of the common rotatorcuff lesions. It affects the quality of life negatively and causes loss of range of motion and muscle strength. It can be seen due to traumatic or degenerative causes. Its incidence increases with advanced age. While the incidence was reported as 4% in the population aged 40-60 years, this rate was reported to be 17-50% in the group over the age of 60 and 80% in the group over the age of 80. Radiologically, classification is made as partial or full-thickness tears. Rotatorcuff tears can be treated conservatively or surgically. Although the risk of post-surgical rupture is reduced with new methods, the lack of desired tendon healing has led to the search for alternative applications such as biological augmentation and high-intensity laser. The aim of this study is to reveal the effectiveness of high-intensity laser therapy in patients with partial supraspinatus tear.

详细描述

90 patients aged 20-60 years who were diagnosed with partial supraspinatus tear and met the inclusion criteria of the study will be included in the study. Patients will be randomized into three groups: 30 patients in the first group who have 5 sessions of high-intensity laser, 30 patients in the second group who have 10 sessions of high-intensity laser, and 30 patients in the third group control group who have only exercises. It was planned to give 5 sessions of laser+exercise every other day to the the first group, 10 sessions of laser+exercise every other day to the second group, and only exercise program three days in a week to the control group. All groups will be evaluated with joint range of motion (ROM) (measurements including abduction, adduction, flexion, extension, internal and external rotation by goniometer according to neutral 0 position), visual analog scale (VAS), shoulder pain dissability index, quickdash, constant score at 0th month, 1st month, 3rd and 6th months.

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
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 20-65 years
  • Patients with VAS>4 pain in the shoulder for at least 3 months
  • Patients with at least 25% loss in the range of motion of the joint compared to the contralateral side, especially in abduction and external rotation, or on physical examination or positivity of at least one of the impingement tests including jobb, lift off, ERLS , speed, yergeson, O Brien's test, dropparm tests or popeye signs.
  • Diagnose of partial supraspinatus with ultrasound or MR

排除标准

  • Patients with incomplete skin integrity, hyperemia, signs of infection or tattoos
  • Patients with suspected full-thickness tear
  • History of rheumatic disease (rheumatoidarthritis, osteoarthritis, PMR)
  • Patients with accompanying shoulder pathology such as calcifictendinitis
  • History of malignancy
  • Surgery, manipulation, mobilization, arthroscopy performed on the affected shoulder
  • Steroid, local anesthetic, hyaluronic acid injection, cnesiotaping or neural therapy in the affected shoulder in the last 3 months
  • Reflex sympathetic dystrophy, neurodeficit in the affected extremity
  • Diabetes patients or any Patients who cannot feel the burning pain due to a peripheral neuropathy or sensory defect
  • Patients with epilepsy

结局指标

主要结局

VAS (visuel analog score)

时间窗: 3rd month

evaluation of pain with scale of between 0 and 10 that means 0 no pain and 10 too much pain.

次要结局

  • Constant score(6 th month)

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

Korhan Barıs Bayram

associate professor doctor

Izmir Katip Celebi University

研究点 (2)

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