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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05031104
Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Riyadh
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Al Kharj, Riyadh, Arabia Saudita
- Ragab K. Elnaggar
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Control group
Patients in this group undergone a standard exercise program.
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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.
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Experimental: LLT group
Patients in this group undergone a standard exercise program as the control group in addition to the LLT.
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The LLT group received the same program in addition to the application of LLT on both knees, each session before exercises.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain intensity
Periodo de tiempo: 2 months
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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".
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2 months
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Muscle performance
Periodo de tiempo: 2 months
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Represented by the peak concentric torque of the quadriceps muscle.
It was measured using an Isokinetic Dynamometer.
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2 months
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Fatigue perception
Periodo de tiempo: 2 months
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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.
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2 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Functional status
Periodo de tiempo: 2 months
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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)
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2 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ragab K Elnaggar, PhD, Cairo University / Prince Sattam Bin Abdulaziz University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Manifestaciones neurológicas
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Enfermedades del tejido conectivo
- Enfermedades Musculares
- Manifestaciones Neuromusculares
- Artritis
- Debilidad muscular
- Enfermedades reumáticas
- Enfermedades del colágeno
- Artritis Juvenil
Otros números de identificación del estudio
- RHPT/0018/027
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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