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临床试验/NCT04779190
NCT04779190已完成不适用

Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome

Istanbul University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change from baseline activity pain score at 1-months and 3-months

研究概览

简要总结

The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and therapeutic ultrasound combined with home-based exercise in comparison with home-based exercise alone in patients with subacromial impingement syndrome (SIS). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).

详细描述

SIS is an important cause of pain and disability and affects activities of daily living. Therefore, a major goal of SIS treatment is to reduce pain and improve upper extremity function. In this prospective, randomized controlled, single-blind, interventional trial, a total of 60 patients with SIS who met the eligibility criteria are going to enrolled in the study. Eligible participants are going to randomly assign to one of the three groups by an independent blinded researcher, using a computer-generated random numbers and allocation ratio of 1:1:1: the LLLT group (LG, n = 20), the ultrasound therapy group (UG, n = 20), and the control group (CG, n = 20). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of subacromial impingement syndrome based on physical examinations
  • Persistent pain in one shoulder for at least 2 months
  • No passive shoulder range of motion limitations
  • Failure of improvement in pain after analgesic medications

排除标准

  • History of malignancy and systemic rheumatic diseases
  • Evidence of systemic or local infection
  • Presence of major trauma at the affected shoulder
  • History of shoulder surgery
  • Rotator cuff lesions in the form of either calcific tendinosis or full-thickness tear as confirmed on MRI scanning

结局指标

主要结局

Change from baseline activity pain score at 1-months and 3-months

时间窗: Baseline, 1-month, 3-month

Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome

次要结局

  • Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months(Baseline, 1-month, 3-month)
  • Change from baseline rest pain score at 1-months and 3-months(Baseline, 1-month, 3-month)
  • Change from baseline night pain score at 1-months and 3-months(Baseline, 1-month, 3-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekin Ilke Sen

Assistant Professor

Istanbul University

研究点 (1)

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