Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05031104
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.4
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis; Rheumatic Diseases; Chronic Knee Pain; Fatigue; Muscle Weakness; Polyarticular JCA	Other: Physical Exercise; Other: Physical Exercise plus Low-energy Laser Therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A prospective, dual-arm, randomized controlled trial with a 6-month follow-upA prospective, dual-arm, randomized controlled trial with a 6-month follow-up
• Masking: Single (Outcomes Assessor)
• Masking Description: This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Oct 21, 2018
• Actual Primary Completion Date: Jan 2, 2020
• Actual Study Completion Date: Jan 2, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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".

2. Muscle performance [2 months]

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

3. 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

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ragab K. Elnaggar	Al Kharj	Riyadh	Saudi Arabia

Sponsors and Collaborators

• Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ragab Kamal Elnaggar, Assistant Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05031104
• Other Study ID Numbers: RHPT/0018/027
• First Posted: Sep 1, 2021
• Last Update Posted: Oct 7, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Rheumatic Diseases; Arthritis, Juvenile; Muscle Weakness; Collagen Diseases

Study Results

No Results Posted as of Oct 7, 2021