- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07604935
Comparative Effects of Nerve Flossing and Deep Neck Flexor Muscle Strengthening on Pain, Range of Motion and Functional Disability on Cervical Spinal Stenosis (NF-DNF)
17 de mayo de 2026 actualizado por: Akasha Khan, Green International University
The goal of this randomized clinical trial is to compare the effectiveness of Nerve Flossing and Deep Neck Flexor strengthening exercises in individuals with cervical spinal stenosis.
The study aims to determine which treatment is more effective in reducing neck pain, improving cervical range of motion, and enhancing the ability to perform daily activities.
Participants will be randomly assigned to receive either Nerve Flossing or Deep Neck Flexor exercises for specified duration.
Both groups will attend physiotherapy sessions 3 times per week as assigned.
Outcomes such as pain intensity, neck disability, and range of motion will be measured before and after the intervention using standard assessment tools.
This study will help identify a more effective physiotherapy approach for managing symptoms of cervical spinal stenosis.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cervical spinal stenosis is a condition characterized by narrowing of the spinal canal in the cervical region, leading to compression of neural structures.
This often results in neck pain, reduced cervical range of motion, and functional disability that affects daily activities and quality of life.
Conservative management through physiotherapy is the preferred initial approach before considering surgical intervention.
Among conservative techniques, Nerve Flossing and Deep Neck Flexor strengthening are commonly used but their comparative effectiveness remains unclear.
Nerve Flossing involves controlled, low-amplitude movements of the neck and upper limb to mobilize neural tissues and reduce nerve-related pain and sensitivity.
Deep Neck Flexor strengthening uses specific low-load exercises to improve the activation and endurance of the deep cervical flexors that support head and neck posture.
This study is conducted to address the gap in evidence by directly comparing these two interventions in patients with cervical spinal stenosis.
The findings will help physiotherapists and clinicians select the most effective treatment approach for reducing pain and improving function in this population.
Tipo de estudio
Intervencionista
Inscripción (Actual)
62
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistán
- Green International University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Adults aged 20-50 years, both male and female.
- Clinical and radiological (MRI) diagnosis of cervical spinal stenosis.
- Cervical pain with or without radiating to the upper limb.
- At least one neurological sign, such as sensory disturbance, muscle weakness or diminished reflexes.
- Symptoms present for more than 4 weeks but less than 6 months.
- Ability to understand and follow exercise instructions.
- VAS pain score ≥ 3/10 at baseline.
Exclusion Criteria:
- History of cervical spine surgery
- Recent trauma, fracture, or cervical instability.
- History of disc herniation involving surgery.
- Other neurological or musculoskeletal conditions, including peripheral neuropathy, thoracic outlet syndrome, and rheumatoid arthritis.
- Pregnancy.
- Recent medication use that may impact nerve function (e.g., systemic steroids).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Nerve Flossing Group
Participants in this arm will receive Nerve Flossing techniques targeting the cervical and upper limb neural tissues.
The intervention involves controlled, low-amplitude movements of the neck and upper limb to improve neural mobility.
Sessions will be conducted as per the study protocol.
|
This intervention involves controlled, low-amplitude movements of the neck and upper limb to mobilize the cervical and upper limb neural tissues.
The technique aims to reduce mechanical sensitivity of the nerves, improve neural mobility, and alleviate nerve-related pain in patients with cervical spinal stenosis.
The specific dosage, frequency, and duration will be applied as per the study protocol.
Otros nombres:
|
|
Experimental: Deep Neck Flexor Strengthening Group
Participants in this arm will receive Deep Neck Flexor strengthening exercises using low-load, targeted movements to improve activation and strength of the deep cervical flexor muscles.
The exercises focus on enhancing cervical stability and posture.
Sessions will be conducted as per the study protocol.
|
Low-load, targeted exercises to improve activation and endurance of the deep cervical flexor muscles.
Focuses on enhancing cervical stability and posture.
Frequency, duration, and repetitions will follow the study protocol.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity
Periodo de tiempo: Baseline and 12 weeks post-intervention
|
Pain intensity will be measured using the Visual Analogue Scale (VAS), where participants mark their pain level on 100mm line ranging from "no pain" (0) to "worst imaginable pain (100).
Higher scores indicate greater pain intensity.
|
Baseline and 12 weeks post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Neck Disability Index Score
Periodo de tiempo: Baseline and 12 weeks post-intervention
|
Change in neck-related disability from baseline to 6 weeks and post-intervention, measured using the Neck Disability Index (NDI) on a scale of 0-50.
Higher scores indicate greater disability.
|
Baseline and 12 weeks post-intervention
|
|
Change in Cervical Range of Motion
Periodo de tiempo: Baseline and 12 weeks post-intervention
|
Change in cervical flexion, extension, and rotation range of motion from baseline to 6 weeks and 12 weeks, measured by using inclinometer.
|
Baseline and 12 weeks post-intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de abril de 2026
Finalización primaria (Actual)
29 de abril de 2026
Finalización del estudio (Actual)
6 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
17 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de mayo de 2026
Publicado por primera vez (Actual)
22 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GIU/REC/26-34
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
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.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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