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Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis

2021年9月29日 更新者:Ragab Kamal Elnaggar、Cairo University

Efficacy of the Articular Application of Low-energy Laser on Knee Joints as an Auxiliary Treatment for Polyarticular Juvenile Idiopathic Arthritis: A Dual-arm Randomized Clinical Trial

This study endeavored to evaluate the auxiliary effect of low-energy laser therapy (LLT) on pain, muscle performance, fatigue, and functional ability in children with juvenile idiopathic arthritis (JIA). Sixty patients with JIA were randomly allocated to the LLT group (n = 30, received LLT in addition to the standard exercise program) or the control group (n = 30, received standard exercise program only). Both groups were assessed for pain intensity, muscle performance, fatigue perception, and functional status.

研究概览

详细说明

Sixty patients with JIA were recruited from the Physical Therapy Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, and the Pediatric Rheumatology Clinic, King Khalid Hospital, Al-Kharj, Saudi Arabia. The study included patients who had a confirmed diagnosis of Polyarticular JIA (according to the criteria set forth by the International League of Associations for Rheumatology), aged 8-16 years, identified being stable cases, and did not participate in a regular exercise program (in the past six months). Patients who had fixed deformities, a history of joint surgery, or whose radiological investigations revealed erosive changes of bone, ankylosing, or fractures were excluded.

Outcome measures

  1. Pain intensity: measures through the Visual Analogue Scale
  2. Muscle performance: represented by the peak concentric torque of the right and left quadriceps muscle and measured through an Isokinetic Dynamometer.
  3. Fatigue perception: tested by the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-MFS)
  4. Functional status: the functional status was quantified using the cross-cultural validated version of the Childhood Health Assessment Questionnaire (CHAQ).

Patients in the control and LLT group received a 40-minute exercise program, three times a week, for three months in succession. Patients in the LLT group additionally underwent an articular application of LLT on the knee joint, each session before exercises (eight points on each knee, 30 seconds irradiation for each point, with a total irradiation dose of eight minutes per session. The treatment was conducted by two experienced pediatric physical therapists.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Riyadh
      • Al Kharj、Riyadh、沙特阿拉伯
        • Ragab K. Elnaggar

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

8年 至 16年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Confirmed diagnosis of JIA
  • Polyarticular onset of JIA with bilateral involvement of the knee joint
  • Age between 8 and 16 years
  • Stable conditions (i.e., receive stable doses of medications in the past three months)
  • Not participating in a regular exercise program in the past six months

Exclusion Criteria:

  • Fixed deformities
  • History of joint surgery
  • Ankylosing or fractures
  • Bone destruction (erosive changes of the knee joint)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Control group
Patients in this group undergone a standard exercise program.
The control group received a standard exercise program for 40 minutes, three times a week for three successive months. The program encompassed aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises.
实验性的:LLT group
Patients in this group undergone a standard exercise program as the control group in addition to the LLT.
The LLT group received the same program in addition to the application of LLT on both knees, each session before exercises.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain intensity
大体时间:2 months
Pain intensity was measured through the Pain Visual Analogue Scale. Each child was asked to indicate his/her perceived pain intensity (most commonly) along a horizontal line (0-10 cm), where 0 represents "no pain" and 10 represents "worst pain".
2 months
Muscle performance
大体时间:2 months
Represented by the peak concentric torque of the quadriceps muscle. It was measured using an Isokinetic Dynamometer.
2 months
Fatigue perception
大体时间:2 months
The extent of fatigue that patients generally perceive was assessed using the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale. Eighteen items across 3 subscales were rated on a 5-point Likert scale (0 = NEVER a problem and 4 = ALWAYS a problem). Item scores were linearly transformed on a 0-100 scale. The total score is calculated as the sum of all item scores divided by the number of rated items. Lower scores represent higher levels of fatigue perception.
2 months

次要结果测量

结果测量
措施说明
大体时间
Functional status
大体时间:2 months
The patient's ability to perform normal daily activities was assessed through the cross-culture validated version of the Childhood Health Assessment Questionnaire (parents-proxy report)
2 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ragab K Elnaggar, PhD、Cairo University / Prince Sattam Bin Abdulaziz University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年10月21日

初级完成 (实际的)

2020年1月2日

研究完成 (实际的)

2020年1月2日

研究注册日期

首次提交

2021年8月28日

首先提交符合 QC 标准的

2021年8月28日

首次发布 (实际的)

2021年9月1日

研究记录更新

最后更新发布 (实际的)

2021年10月7日

上次提交的符合 QC 标准的更新

2021年9月29日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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