Efectos de la Educación en Neurociencia del Dolor con Entrenamiento en Discriminación Sensorial entre Pacientes con Dolor Lumbar Crónico
Efectos de la Educación en Neurociencia del Dolor con Entrenamiento en Discriminación Sensorial sobre la Catastrofización del Dolor, la Cinesiofobia y los Movimientos Funcionales en Pacientes con Dolor Lumbar Crónico: Un Ensayo Controlado Aleatorizado
The current study is a double-blind, parallel-group randomized controlled trial involving 80 participants with chronic low back pain. The trial will compare a program of Pain Neuroscience Education plus Sensory Discrimination Training and core stability exercises with a program of Pain Neuroscience Education and core stability exercises alone. Interventions will be delivered twice weekly for eight weeks. The primary outcome is pain catastrophizing. Secondary outcomes include kinesiophobia and functional movements. Assessments will be conducted at baseline, 4, and 8 weeks. The trial will be carried out at Nutricao Lahore Clinic and Model Town Hospital, Lahore. The hypothesis is that Pain Neuroscience Education with Sensory Discrimination Training will result in greater reductions in pain catastrophizing and kinesiophobia, as well as improvements in functional movements.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Chronic low back pain is a complex condition influenced by biological, psychological, and sensory factors. Pain Neuroscience Education has been shown to reduce maladaptive pain beliefs and improve pain processing, while Sensory Discrimination Training targets altered cortical representation that frequently occurs in chronic pain conditions. Combining these approaches may offer a complementary effect by addressing both cognitive and sensory dimensions of pain.
This study will evaluate the added value of Sensory Discrimination Training when delivered alongside Pain Neuroscience Education and core stability exercises, compared with a control intervention combining Pain Neuroscience Education, and core stability exercises. The trial uses a double-blind, parallel-group randomized controlled design with a total of 80 participants diagnosed with chronic low back pain.
Participants will be randomly assigned to one of two intervention groups. The experimental group will receive structured Pain Neuroscience Education sessions, Sensory Discrimination Training using surface-based tactile discrimination tasks, and a standardized core stability exercise program. The comparison group will receive the same Pain Neuroscience Education protocol, and the same core stability exercise program. Both interventions will be provided twice per week for eight weeks, with each session lasting 45 minutes.
The study aims to investigate whether the addition of Sensory Discrimination Training results in greater improvements in pain-related cognitions, fear-related movement avoidance, and functional movement performance. The primary mechanism of interest is the potential effect of Sensory Discrimination Training on improving cortical sensory mapping, which may contribute to reduced pain catastrophising and improved motor function. Outcome measures will be assessedat baseline, 4, and 8 weeks (end of intervention). The current study will be conducted at Nutricao Lahore Clinic and Model Town Hospital Lahore under standardized procedures to ensure intervention fidelity and consistent delivery across sessions.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: MUHAMMAD TARIQ RAFIQ, PhD
- Correo electrónico: tariq.rafiq@ubas.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: MUHAMMAD SAAD JANJUA
- Número de teléfono: +923167995435
- Correo electrónico: ubs24lmspt023@ubas.edu.pk
Ubicaciones de estudio
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Lahore, Pakistán
- Reclutamiento
- 1. Boston Physical Therapy Centre Lahore. 2. Nutricao Clinic Lahore. 3. Model Town Hospital Lahore
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age: 19 to 44 Both Genders Mechanical low back pain (duration more than 6 months and less than 2 years) >4/10 Numerical Pain Rating Scale (NPRS)
Exclusion Criteria:
- Pregnancy or post-partum Trauma Psychological Pain Radicular Pain Cancer, tumor, malignancy Neurological Deficit Recent Surgery <1year
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Experimental Group
Participants in the experimental group will receive a 45-minute intervention session consisting of three integrated components (Pain Neuroscience Education, Core Stability Exercises and Graded Sensory Discrimination Training ) |
Although both Pain Neuroscience Education and Sensory Discrimination Training have demonstrated potential benefits individually, there is a paucity of research evaluating their combined effects. Integrating cognitive (PNE) and sensorimotor (SDT) approaches may produce synergistic effects, improving pain modulation, functional capacity, and psychological resilience. |
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Comparador activo: Control group
Participants in the control group will receive the same 45-minute sessions consisting of two components (Pain Neuroscience Education and Core Stability Exercises). |
Participants in the control group will receive the same 45-minute sessions twice per week, but will not receive sensory discrimination training. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Catastrophizing
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
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Pain catastrophizing refers to a maladaptive cognitive and emotional response to actual or perceived pain. Pain Catastrophizing is measured by the Pain Catastrophizing Scale. The Pain Catastrophizing Scale is a validated questionnaire used to measure the degree of catastrophic thinking in individuals experiencing pain (Sullivan et al. 1995). The scale consists of 13 items, each representing a different catastrophizing response. For each item, participants rate their experience using a 5-point Likert scale, where 0 = Not at all (the thought or feeling never occurred) and 4 = All the time (the thought or feeling occurred persistently). The total score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. |
From enrollment to the end of treatment at 8 weeks
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Kinesiophobia
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
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Kinesiophobia is a debilitating fear of movement and physical activity due to the belief that movement will cause pain or re-injury. Kinesiophobia is measured by the Tampa Scale for Kinesiophobia. Tampa Scale for Kinesiophobia is the most widely used and validated tool to assess the fear of movement or re-injury. It contains 17 items. Each item is scored using a 4-point Likert scale with 1 = strongly disagree and 4 = strongly agree. Total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia. |
From enrollment to the end of treatment at 8 weeks
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Functional Movements
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
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Functional movement refers to the basic movements that people need in daily life to perform normal activities safely and efficiently. These movements involve multiple joints and muscle groups working together in a coordinated way. Functional movements will be assessed using 2D motion analysis through the Kinovea software. Participants will perform two standardized tasks: forward bending and sit-to-stand. All movements will be recorded using a fixed camera positioned at a consistent height (e.g., 1.2 m) and distance (e.g., 2.5 m) from the participant. Kinovea will be used to extract trunk flexion angle, lumbar deviation from the midline, pelvic tilt angle and task completion time. Higher movement quality, reduced deviation, and faster task completion will be interpreted as improved functional performance. |
From enrollment to the end of treatment at 8 weeks
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: MUHAMMAD TARIQ RAFIQ, Lahore University of Biological & Applied Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- UBAS/ERB/FoRS/25/028
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Only IPD used in the results publication will be shared.
Marco de tiempo para compartir IPD
It will be available after the completion of the study.
Criterios de acceso compartido de IPD
Through the corresponding author.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
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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