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Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis

Primary Purpose

Juvenile Idiopathic Arthritis, Rheumatic Diseases, Chronic Knee Pain

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Physical Exercise
Physical Exercise plus Low-energy Laser Therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ragab K. Elnaggar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

LLT group

Arm Description

Patients in this group undergone a standard exercise program.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
August 28, 2021
Last Updated
September 29, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05031104
Brief Title
Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2018 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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 Pain intensity: measures through the Visual Analogue Scale Muscle performance: represented by the peak concentric torque of the right and left quadriceps muscle and measured through an Isokinetic Dynamometer. Fatigue perception: tested by the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-MFS) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis, Rheumatic Diseases, Chronic Knee Pain, Fatigue, Muscle Weakness, Polyarticular JCA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, dual-arm, randomized controlled trial with a 6-month follow-up
Masking
Outcomes Assessor
Masking Description
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in this group undergone a standard exercise program.
Arm Title
LLT group
Arm Type
Experimental
Arm Description
Patients in this group undergone a standard exercise program as the control group in addition to the LLT.
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Intervention Description
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
Intervention Name(s)
Physical Exercise plus Low-energy Laser Therapy
Intervention Description
The LLT group received the same program in addition to the application of LLT on both knees, each session before exercises.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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".
Time Frame
2 months
Title
Muscle performance
Description
Represented by the peak concentric torque of the quadriceps muscle. It was measured using an Isokinetic Dynamometer.
Time Frame
2 months
Title
Fatigue perception
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Functional status
Description
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)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragab K Elnaggar, PhD
Organizational Affiliation
Cairo University / Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ragab K. Elnaggar
City
Al Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis

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