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临床试验/NCT04751253
NCT04751253Unknown不适用

The Combined Effect Of Different Doses Of High-Intensity Laser And Traditional Exercise On Pain And Function In Patients With Chronic Knee Osteoarthritis

Cairo University0 个研究点目标入组 51 人开始时间: 2021年2月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
51
主要终点
visual analogue scale

研究概览

简要总结

The purpose of the study is to compare the effect of different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.

详细描述

Adding HILT to the traditional physical therapy program may reduce pain and improve the functional status of the affected joints. This may provide clinicians with an understanding of the different treatment modalities that may improve the quality of life of patients suffering from chronic knee OA. Which may benefit a wide range of individuals affected by this chronic and widespread disease all over the world.

Although little is known about the efficacy or mechanism of action of what has been termed ''high-intensity laser therapy'' using Nd: YAG lasers it has become commercially available in veterinary practice and is being marketed for the treatment of musculoskeletal disease. clinical research specific to Nd: YAG high-intensity laser therapy is required, as it is being used with little supporting evidence.

As there was no evidence about the best protocol for the treatment of knee OA as each study was using different doses, different sites of application, different number of phases, frequency of sessions, and the interval between sessions that make it difficult to have the best results. Specifically, the dosage range in literature was ranged from 1250 to 3000 J as total energy transmitted during one treatment session. The current study is an attempt to answer the question of which dosage of the energy of high-intensity LASER is more effective on pain and functional activities in patients with chronic knee OA at the third degree of osteoarthritis as determined by (Kellgren/Lawrence grading system) as it was recommended that LASER is an ideal treatment for subjects in the later stages of OA .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).
  • Aged between 50- 70 years
  • Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.
  • Body mass index (BMI) ≤30 kg/m
  • Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
  • All subjects who will participate in this study will read, sign and date an informed consent form which required by ethical committee of faculty of physical therapy, Cairo university

排除标准

  • Patients will be excluded if they have the following conditions:
  • History of joint replacement.
  • Symptoms or signs suggestive of another cause of knee pain.
  • Rheumatoid arthritis.
  • Steroid injection or knee surgery (previous six months).
  • acute inflammation around knee joint.
  • Underlying disease such as malignancy.
  • Infection or systemic disease of musculoskeletal system

结局指标

主要结局

visual analogue scale

时间窗: 8 weeks

pain intensity

The functional disability assessment

时间窗: 8 weeks

The Western Ontario and McMaster Universities Osteoarthritis Index

次要结局

未报告次要终点

研究者

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

Mona Mohamed Ibrahim

Assistant Professor

Cairo University

相似试验

High Intensity Laser and Exercises in Knee OA | 临床试验