- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07723001
Effects of Thoracic Spine and Cervical Spine Mobilization on Pain, Functional Disability, and Quality of Life in Patients With Mechanical Neck Pain.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Mechanical neck pain (MNP) is a common musculoskeletal condition characterized by localized or unilateral neck pain arising from cervical musculoskeletal structures, without nerve root involvement. It is frequently associated with restricted cervical and thoracic mobility, muscle stiffness, reduced range of motion, and functional limitations, which can significantly impair daily activities, work performance, and overall quality of life. Due to its high prevalence and recurrent nature, effective conservative physiotherapy management is essential.
Among commonly used physiotherapy interventions, spinal mobilization techniques particularly cervical spine mobilization and thoracic spine mobilization are widely applied to reduce pain, improve joint mobility, and enhance functional outcomes. Cervical mobilization focuses on restoring segmental mobility of the cervical spine and modulating pain through mechanical and neurophysiological mechanisms. In contrast, thoracic spine mobilization targets the upper thoracic region to improve extension mobility and reduce biomechanical stress on the cervical spine through the concept of regional interdependence. Although both techniques are frequently used in clinical practice, there is limited comparative evidence regarding their individual and combined effectiveness in patients with mechanical neck pain.
This study is designed as a two-arm parallel randomized controlled trial. A total of 66 participants diagnosed with mechanical neck pain will be recruited using a convenience sampling technique. Participants will be randomly allocated into two groups using computer-generated randomization with a 1:1 allocation ratio. Allocation concealment will be ensured using sealed opaque envelopes, and outcome assessment will be performed by a blinded assessor.
Participants in Group A will receive cervical spine Maitland mobilization applied to symptomatic cervical segments (C2-C7) using graded oscillatory techniques for pain reduction and mobility improvement. Participants in Group B will receive combined thoracic and cervical spine Maitland mobilization, where thoracic mobilization will be applied to upper thoracic segments (T1-T4) followed by cervical mobilization within the same session.
Both groups will receive standardized physiotherapy care, including patient education on posture and ergonomics, along with a structured home exercise program focusing on cervical mobility and postural control. The intervention will be conducted over a period of 8 weeks, with 2 sessions per week. Each session will last approximately 30 minutes.
Outcome measures will include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), functional disability measured by the Neck Disability Index (NDI), and quality of life evaluated using the Short Form-36 (SF-36). Assessments will be conducted at baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
Data will be analyzed using SPSS software. Normality of data will be assessed using the Shapiro-Wilk test, and appropriate parametric or non-parametric tests will be applied for within-group and between-group comparisons.
This study aims to provide evidence regarding the effectiveness of cervical spine mobilization alone versus combined thoracic and cervical spine mobilization in improving pain, functional disability, and quality of life in patients with mechanical neck pain, thereby contributing to evidence-based physiotherapy practice.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr.Tariq Shafi, MSPT
- Número de teléfono: +923454190056
- Correo electrónico: muhammad.tariq@ubas.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Ahmad Arshad, MSPT
- Número de teléfono: +923018822967
- Correo electrónico: Mianahmadarshad3@gmail.com
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 53400
- Reclutamiento
- Lahore University of Biological & Applied Sciences (UBAS)
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Contacto:
- Dr.Muhammad Tariq Shafi, MSPT
- Número de teléfono: +923454190056
- Correo electrónico: muhammad.tariq@ubas.edu.pk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Participants of both genders aged between 20 and 40 years with a clinical diagnosis of mechanical neck pain will be included in the study. Eligible participants must have a history of neck pain lasting more than 4 weeks (subacute to chronic) and demonstrate mild to moderate functional disability, defined by a Neck Disability Index (NDI) score between 10% and 50%.
Exclusion Criteria:
Participants will be excluded if they present with signs or symptoms of cervical radiculopathy or myelopathy, such as a positive Spurling's test accompanied by neurological deficits, dermatomal numbness, or myotome weakness. Individuals with a history of cervical spine fracture, dislocation, or spinal surgery, as well as those with inflammatory, infectious, or neoplastic spinal conditions, will also be excluded. Additional exclusion criteria include diagnosed osteoporosis or prolonged use of systemic corticosteroids, severe cervical spine instability or vertebrobasilar insufficiency, recent trauma to the cervical or thoracic spine within the past 6 months, presence of systemic neurological disorders, pregnancy, and current participation in another physiotherapy or clinical trial for neck pain.
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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Experimental: Cervical Spine Maitland Mobilization
Participants in this group will receive cervical spine Maitland mobilization along with standardized physiotherapy care, including patient education on posture, ergonomics, and a structured home exercise program.
The intervention will be conducted for 8 weeks, with 2 sessions per week, each lasting approximately 30 minutes.
Cervical mobilization will be applied to symptomatic segments (C2-C7) using graded oscillatory techniques to reduce pain and improve cervical mobility
|
Participants in this group will receive cervical spine Maitland mobilization in addition to standard physiotherapy care.
The program will be delivered for 8 weeks, with 2 sessions per week, each session lasting approximately 30 minutes.
Mobilization will be performed according to the Maitland concept, with Grades I and II techniques applied for pain modulation and Grades III and IV for improving joint mobility, depending on patient tolerance.
Each targeted cervical segment (C2-C7) will receive 3 sets of oscillations lasting 30-60 seconds, with short rest intervals between sets.
The intervention aims to restore segmental mobility, reduce pain, and improve functional outcomes.
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Comparador activo: Thoracic plus Cervical Spine Maitland Mobilization
Participants in this group will receive combined thoracic and cervical spine Maitland mobilization along with standardized physiotherapy care, including posture education and a structured home exercise program.
The intervention will be conducted for 8 weeks, with 2 sessions per week, each lasting approximately 30 minutes.
Thoracic mobilization will be applied to improve thoracic mobility, followed by cervical mobilization to reduce pain and enhance function.
|
Participants in this group will receive combined thoracic and cervical spine Maitland mobilization in addition to standard physiotherapy care.
The program will be conducted for 8 weeks, with 2 sessions per week, each session lasting approximately 30 minutes.
Thoracic mobilization will be applied to upper thoracic segments (T1-T4) using central posterior-to-anterior oscillatory techniques, primarily Grades III and IV to improve extension mobility.
This will be followed by cervical spine mobilization using the same protocol as Group A. Thoracic mobilization will be performed for approximately 6-8 minutes, followed by cervical mobilization for 8-10 minutes.
The combined approach aims to reduce cervical mechanical stress through regional interdependence, improve mobility, and enhance pain relief and functional outcomes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Numeric Pain Rating Scale, Neck Disability Index, Short Form-36 (SF-36)
Periodo de tiempo: Baseline, 4 weeks, and 8 weeks
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Outcome assessment will be conducted at baseline (pre-treatment), at 4 weeks (mid-intervention), and at 8 weeks (post-intervention).
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), functional disability using the Neck Disability Index (NDI), and quality of life using the Short Form-36 (SF-36).
Data will be analyzed using appropriate statistical tests to compare within-group and between-group differences.
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Baseline, 4 weeks, and 8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Shoaib Waqas, Lahore University of Biological and Applied Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- UBAS/ERB/26/04/021
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Start Date: De-identified individual participant data (IPD) along with supporting materials will be made available following publication of the main trial findings, anticipated around 12 months after the study concludes.
End Date: The data will be accessible for a period of 5 years from the commencement date to eligible researchers who provide a formal application and consent to the data use agreement.
Criterios de acceso compartido de IPD
De-identified individual participant data (IPD) along with supporting documents will be available to qualified researchers for academic and non-commercial use only. To access the data, researchers must submit a written application detailing their study objectives and proposed use of the dataset. All requests will be assessed by the principal investigator Irsa and the institutional ethics committee to ensure ethical compliance and protection of participant privacy.
Data Available:
The shared dataset will include anonymized participant information, such as age and sex.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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