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临床试验/NCT05031104
NCT05031104已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月21日最近更新:
适应症
干预措施

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
Pain intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Control group

Active Comparator

Patients in this group undergone a standard exercise program.

干预措施: Physical Exercise (Other)

LLT group

Experimental

Patients in this group undergone a standard exercise program as the control group in addition to the LLT.

干预措施: Physical Exercise plus Low-energy Laser Therapy (Other)

结局指标

主要结局

Pain intensity

时间窗: 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".

Muscle performance

时间窗: 2 months

Represented by the peak concentric torque of the quadriceps muscle. It was measured using an Isokinetic Dynamometer.

Fatigue perception

时间窗: 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.

次要结局

  • Functional status(2 months)

研究者

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

Ragab Kamal Elnaggar

Assistant Professor

Cairo University

研究点 (1)

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