Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Kharj, Riyadh, Saudi Arabia
      • Ragab K. Elnaggar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients in this group undergone a standard exercise program.	Other: Physical Exercise; 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.
Experimental: LLT group; Patients in this group undergone a standard exercise program as the control group in addition to the LLT.	Other: Physical Exercise plus Low-energy Laser Therapy; The LLT group received the same program in addition to the application of LLT on both knees, each session before exercises.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ragab K Elnaggar, PhD, Cairo University / Prince Sattam Bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2018
• Primary Completion (Actual): January 2, 2020
• Study Completion (Actual): January 2, 2020

Study Registration Dates

• First Submitted: August 28, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Manifestations; Arthritis; Muscle Weakness; Rheumatic Diseases; Collagen Diseases; Arthritis, Juvenile
• Other Study ID Numbers: RHPT/0018/027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No