Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis

NCT ID: NCT05031104

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-21
• Study Completion Date: 2020-01-02

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.

Conditions

Juvenile Idiopathic Arthritis; Rheumatic Diseases; Chronic Knee Pain; Fatigue; Muscle Weakness; Polyarticular JCA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Patients in this group undergone a standard exercise program.

Group Type: ACTIVE_COMPARATOR

Physical Exercise

Intervention Type: OTHER

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.

LLT group

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

Group Type: EXPERIMENTAL

Physical Exercise plus Low-energy Laser Therapy

Intervention Type: OTHER

The LLT group received the same program in addition to the application of LLT on both knees, each session before exercises.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ragab Kamal Elnaggar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ragab K Elnaggar, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University / Prince Sattam Bin Abdulaziz University

Locations

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RHPT/0018/027

Identifier Type: -

Identifier Source: org_study_id