Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 9:27 PM
Study NCT ID:
NCT05031104
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2021-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, dual-arm, randomized controlled trial with a 6-month follow-up'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-08-28', 'studyFirstSubmitQcDate': '2021-08-28', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '2 months', '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".'}, {'measure': 'Muscle performance', 'timeFrame': '2 months', 'description': 'Represented by the peak concentric torque of the quadriceps muscle. It was measured using an Isokinetic Dynamometer.'}, {'measure': 'Fatigue perception', 'timeFrame': '2 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Functional status', 'timeFrame': '2 months', '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)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis', 'Rheumatic Diseases', 'Chronic Knee Pain', 'Fatigue', 'Muscle Weakness', 'Polyarticular JCA']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOutcome measures\n\n1. Pain intensity: measures through the Visual Analogue Scale\n2. Muscle performance: represented by the peak concentric torque of the right and left quadriceps muscle and measured through an Isokinetic Dynamometer.\n3. Fatigue perception: tested by the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL-MFS)\n4. Functional status: the functional status was quantified using the cross-cultural validated version of the Childhood Health Assessment Questionnaire (CHAQ).\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of JIA\n* Polyarticular onset of JIA with bilateral involvement of the knee joint\n* Age between 8 and 16 years\n* Stable conditions (i.e., receive stable doses of medications in the past three months)\n* Not participating in a regular exercise program in the past six months\n\nExclusion Criteria:\n\n* Fixed deformities\n* History of joint surgery\n* Ankylosing or fractures\n* Bone destruction (erosive changes of the knee joint)'}, 'identificationModule': {'nctId': 'NCT05031104', 'briefTitle': 'Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RHPT/0018/027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients in this group undergone a standard exercise program.', 'interventionNames': ['Other: Physical Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'LLT group', 'description': 'Patients in this group undergone a standard exercise program as the control group in addition to the LLT.', 'interventionNames': ['Other: Physical Exercise plus Low-energy Laser Therapy']}], 'interventions': [{'name': 'Physical Exercise', 'type': 'OTHER', '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.', 'armGroupLabels': ['Control group']}, {'name': 'Physical Exercise plus Low-energy Laser Therapy', 'type': 'OTHER', 'description': 'The LLT group received the same program in addition to the application of LLT on both knees, each session before exercises.', 'armGroupLabels': ['LLT group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Kharj', 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Ragab K. Elnaggar', 'geoPoint': {'lat': 24.15541, 'lon': 47.33457}}], 'overallOfficials': [{'name': 'Ragab K Elnaggar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University / Prince Sattam Bin Abdulaziz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ragab Kamal Elnaggar', 'investigatorAffiliation': 'Cairo University'}}}}