- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07577778
Effect of Virtual Reality Training on Pain, Functional Disability, and Lumbar Reposition Error in Patients With Chronic Non-Specific Low Back Pain
Effect of Virtual Reality Training on Pain, Functional Disability, and Lumbar Reposition Error in Patients With Chronic Non-Specific Low Back Pain: A Randomized Control Trial
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This randomized controlled trial was conducted to evaluate the effectiveness of virtual reality (VR) training in patients with chronic non-specific low back pain (CNSLBP). Chronic low back pain is a highly prevalent condition associated with impaired proprioception, altered motor control, and functional disability.
Fifty participants diagnosed with CNSLBP were randomly assigned into two groups. The intervention group received virtual reality-based training in addition to conventional physiotherapy, while the control group received conventional treatment alone.
Outcome measures included pain intensity assessed by the Visual Analogue Scale (VAS), functional disability assessed by the Oswestry Disability Index (ODI), and lumbar repositioning error measured using an iPhone inclinometer application.
The study aimed to determine whether VR training could significantly improve pain, functional outcomes, and proprioceptive accuracy in this population.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Giza, Egipto, 12613
- Cairo University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients with low back pain ≥ 12 weeks Age: 21-45 years Both genders BMI: 18.5-24.9
Exclusion Criteria:
- iabetic neuropathy Sciatica Spine deformities Previous lumbar surgery Neurological or vestibular disorders Visual disorders Malignancy or trauma Structural spinal disorders (stenosis, osteoporosis, etc.)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Arm 1
Participants in this group received conventional physiotherapy including TENS, therapeutic ultrasound, and proprioceptive exercises.
|
TENS was applied in a prone position with electrodes placed over the painful area.
Low-frequency stimulation (2-10 Hz) was used to achieve analgesic effects.
Intensity was adjusted to produce a strong but comfortable tingling sensation.
Each session lasted 20-60 minutes.
Ultrasound therapy was applied using appropriate frequency (1 MHz for deep tissues, 3 MHz for superficial tissues) and intensity (0.5-2.0 W/cm²).
Continuous or pulsed modes were selected based on the condition.
Each session lasted 5-10 minutes.
Participants performed trunk stabilization exercises including supine bridge, supine bridge on Swiss ball, and prone plank.
Each exercise was performed for 30 seconds with 30 seconds rest, repeated 5 times, 3 sets per session, 3 times per week.
|
|
Experimental: Group 2
Participants in this group received the same conventional physiotherapy program in addition to virtual reality (VR) training.
|
TENS was applied in a prone position with electrodes placed over the painful area.
Low-frequency stimulation (2-10 Hz) was used to achieve analgesic effects.
Intensity was adjusted to produce a strong but comfortable tingling sensation.
Each session lasted 20-60 minutes.
Ultrasound therapy was applied using appropriate frequency (1 MHz for deep tissues, 3 MHz for superficial tissues) and intensity (0.5-2.0 W/cm²).
Continuous or pulsed modes were selected based on the condition.
Each session lasted 5-10 minutes.
Participants performed trunk stabilization exercises including supine bridge, supine bridge on Swiss ball, and prone plank.
Each exercise was performed for 30 seconds with 30 seconds rest, repeated 5 times, 3 sets per session, 3 times per week.
Participants underwent VR training using Xbox 360 Kinect system. The setup included a motion sensor and projector, allowing full-body interaction through game-based activities. Training consisted of interactive games (e.g., rafting, running, ball hitting) designed to improve trunk control and motor function. Sessions were conducted twice weekly for 30 minutes over 12 weeks. Exercises included movements such as jumping, trunk tilting, and arm coordination, with progressive difficulty levels. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Pain intensity (VAS)
Periodo de tiempo: 1 Month
|
1 Month
|
|
Functional disability (Oswestry Disability Index)
Periodo de tiempo: 1 Month
|
1 Month
|
|
Lumbar reposition error (iPhone inclinometer)
Periodo de tiempo: 1 Month
|
1 Month
|
Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- P.T.REC/012/00604
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .