- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07805265
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Discogenic sciatica is commonly associated with pain, functional limitations, and alterations in gait performance resulting from nerve root involvement and impaired neuromuscular control. Sensorimotor training is an active rehabilitation approach that integrates sensory input with motor responses and may improve proprioception, postural control, balance, and movement coordination.
This study will investigate the additional effect of sensorimotor training in patients with chronic discogenic sciatica. Participants will receive a conventional physical therapy program consisting of interferential current therapy, hot packs, positioning according to directional preference, and static abdominal and back exercises. The experimental intervention will incorporate additional sensorimotor training, including proprioceptive neuromuscular facilitation (PNF)-based trunk exercises, balance training on unstable surfaces, colored-path sensorimotor exercises, and the Star Excursion Balance Exercise.
The sensorimotor program will use progressive task-specific exercises designed to challenge proprioception, balance, trunk control, and neuromuscular coordination. Exercise difficulty will be gradually progressed according to participants' abilities through changes in surface stability, movement complexity, reach distance, walking speed, and the incorporation of dual-task activities.
The study will evaluate changes in spatiotemporal gait parameters, pressure-pain threshold, and functional disability before and after the intervention. The findings may provide evidence regarding whether adding sensorimotor training to conventional physical therapy offers additional benefits for gait performance, pain-related outcomes, and functional ability in patients with chronic discogenic sciatica.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yara Ahmed Mansour, B.Sc
- Número de teléfono: +20 10 08350127
- Correo electrónico: yara.a.mansour@deltauniv.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Hend Mohammad Elsayed Ismail, PhD
Ubicaciones de estudio
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Gamasa, Egipto
- Outpatient clinic at the Faculty of Physical Therapy, Delta University
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Contacto:
- Yara Ahmed Mansour, B.Sc
- Número de teléfono: +20 10 08350127
- Correo electrónico: yara.a.mansour@deltauniv.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Thirty patients of both sexes diagnosed with lumbar disc herniation affecting the L4-L5 and/or L5-S1 nerve roots will be included in this study.
- Presence of lumbar disc herniation (LDH) will be confirmed by magnetic resonance imaging (MRI).
- Age will range from 30 to 55 years.
- Patients experiencing radiating pain along the sciatic nerve distribution (symptoms persisting for more than 3 months).
- All patients must be employed in office-based jobs.
- Berg Balance Scale score will range from 21 to 40 (moderate balance impairment).
- Body Mass Index (BMI) will be within the normal to overweight range (18.5 29.9 kg/m²).
- All the patients will be able to walk independently with or without minimal assistance.
Exclusion Criteria:
- Patients with a history of spinal surgery will be excluded.
- Presence of central neurological disorders (e.g., stroke).
- Patients with other causes of low back pain which is not related to discogenic origin.
- Affections of the musculoskeletal system including fractures.
- Patients with severe balance impairment (Berg Balance Scale score < 21).
- Presence of vestibular disorders or visual impairments affecting balance.
- Patients are currently participating in other rehabilitation programs.
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 |
|---|---|
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Comparador activo: Standard physical therapy
Participants in this arm will receive a standard physical therapy program consisting of interferential current therapy, hot packs, positioning according to directional preference, and static abdominal and back exercises.
The treatment will be administered three sessions per week for two months, with each session lasting approximately 45-60 minutes.
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Standard physical therapy will include interferential current therapy applied over the lumbar region at 80-100 Hz for 15-20 minutes, hot packs applied over the lumbar paraspinal region for 10 minutes, positioning according to the patient's directional preference for 10 minutes or as tolerated, and static abdominal and back exercises targeting the transversus abdominis and multifidus.
The exercises will be performed as 3 sets of 10 repetitions, with each contraction held for 10 seconds followed by 5 seconds of rest.
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Experimental: Sensorimotor Training Plus Standard Physical Therapy
Participants in this arm will receive the same standard physical therapy program administered to the active comparator arm, in addition to a sensorimotor training program.
The sensorimotor training will include PNF-based trunk exercises, balance training on unstable surfaces, colored-path sensorimotor exercises, and the Star Excursion Balance Exercise.
The treatment will be administered three sessions per week for two months, with each session lasting approximately 45-60 minutes.
|
Standard physical therapy will include interferential current therapy applied over the lumbar region at 80-100 Hz for 15-20 minutes, hot packs applied over the lumbar paraspinal region for 10 minutes, positioning according to the patient's directional preference for 10 minutes or as tolerated, and static abdominal and back exercises targeting the transversus abdominis and multifidus.
The exercises will be performed as 3 sets of 10 repetitions, with each contraction held for 10 seconds followed by 5 seconds of rest.
Sensorimotor training will include PNF-based trunk exercises, balance training on unstable surfaces, colored-path sensorimotor exercises, and the Star Excursion Balance Exercise.
The program will incorporate progressive challenges to trunk control, balance, proprioception, and neuromuscular coordination.
Progression will include unstable surfaces, alternating limb movements, single-leg and cross bridging, increased walking speed, dual-task activities, increased reach distance, and increased exercise complexity according to patient tolerance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Walking Speed
Periodo de tiempo: 2 months
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Walking speed will be assessed using the FreeMed® baropodometric platform with FREESTEP software and reported in meters per second (m/s).
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2 months
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Stride Length
Periodo de tiempo: 2 months
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Stride length will be assessed using the FreeMed® baropodometric platform with FREESTEP software and reported in millimeters (mm).
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2 months
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Cadence
Periodo de tiempo: 2 months
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Cadence will be assessed using the FreeMed® baropodometric platform with FREESTEP software and reported as steps per minute (steps/min).
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2 months
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Stance Time
Periodo de tiempo: 2 months
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Stance time will be assessed using the FreeMed® baropodometric platform with FREESTEP software and reported in seconds (s).
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2 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pressure-Pain Threshold
Periodo de tiempo: 2 months
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Pressure-pain threshold will be assessed using a pressure algometer at the lumbar paraspinal, gluteus medius, and piriformis muscles.
Higher values indicate greater pressure-pain tolerance.
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2 months
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Functional Disability
Periodo de tiempo: 2 months
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Functional disability will be assessed using the Oswestry Disability Index (ODI).
The score will be expressed as a percentage from 0% to 100%, with higher scores indicating greater disability.
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2 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Moshera Hassan Darwiesh, PhD, Professor, Cairo University
- Director de estudio: Omar Mohamed Said, PhD, Lecturer, Cairo University
- Director de estudio: Hend Mohammad Elsayed Ismail, PhD, Lecturer, Delta University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- F.PT. 2607107
Información sobre medicamentos y dispositivos, documentos del estudio
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