Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis

Not Applicable

Completed

• Conditions: Juvenile Idiopathic Arthritis; Muscle Weakness; Rheumatic Diseases; Chronic Knee Pain; Fatigue; Polyarticular JCA
• Interventions: Other: Physical Exercise; Other: Physical Exercise plus Low-energy Laser Therapy

• Registration Number: NCT05031104
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-10-21
• Primary Completion: 2020-01-02
• Study Completion: 2020-01-02
• Study First Submitted: 2021-08-28
• Study First Submitted QC: 2021-08-28
• Status Verified: 2021-09
• Study First Posted: 2021-09-01
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Physical Exercise	Patients in this group undergone a standard exercise program.
LLT group	Physical Exercise plus Low-energy Laser Therapy	Patients in this group undergone a standard exercise program as the control group in addition to the LLT.

Primary Outcome Measures

Name	Time	Method
Pain intensity	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	2 months	Represented by the peak concentric torque of the quadriceps muscle. It was measured using an Isokinetic Dynamometer.
Fatigue perception	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.

Secondary Outcome Measures

Name	Time	Method
Functional status	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)

Trial Locations

Locations (1)

Ragab K. Elnaggar; 🇸🇦 Al Kharj, Riyadh, Saudi Arabia