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
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis
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)
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
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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