Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
7 de septiembre de 2026 actualizado por: Ibadat International University, Islamabad
This randomized controlled trial will evaluate the effectiveness of pressure biofeedback-assisted deep cervical flexor training with and without scapular stabilization exercises in patients with cervical spondylosis.
The study will compare the effects of the two treatment approaches on pain intensity, cervical range of motion and neck disability.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
Participants with radiologically confirmed cervical spondylosis will be recruited according to predefined inclusion and exclusion criteria. A total of 44 participants will be recruited, with 22 participants allocated to each group after accounting for an anticipated 10% loss to follow-up.
Participants will be randomly allocated using the sealed envelope method into two groups. Group A will receive pressure biofeedback-assisted deep cervical flexor training combined with scapular stabilization exercises and standard physiotherapy. Group B will receive pressure biofeedback-assisted deep cervical flexor training without scapular stabilization exercises, along with standard physiotherapy.
Treatment will be provided three times per week for four weeks, with each session lasting approximately 30-40 minutes. Outcomes will be assessed at baseline and after completion of the four-week intervention.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
44
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.
Estudio Contacto
- Nombre: Aqsa Anwar
- Número de teléfono: 0321-5172551
- Correo electrónico: aqsaanwer.pt@gmail.com
Ubicaciones de estudio
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistán
- Reclutamiento
- Hope Physiotherapy Clinic
-
Contacto:
- Nida Khan
- Número de teléfono: 0331-0404000
- Correo electrónico: knida816@gmail.com
-
-
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:
- Both genders aged 40-60 years.
- Presence of chronic neck pain for ≥3 months with NPRS ≥3.
- Radiologically confirmed cervical spondylosis, including cervical spine X-ray showing disc space narrowing and/or osteophyte formation.
- Ability to perform active cervical and shoulder movements without neurological deficits.
- Willingness to participate in the study and comply with the intervention protocol.
Exclusion Criteria:
- History of cervical spine surgery or trauma in the past 6 months.
- Severe neurological involvement, including cervical myelopathy or severe radiculopathy with motor weakness, gait disturbance, or bowel/bladder involvement.
- Inflammatory or systemic musculoskeletal disorders, e.g., rheumatoid arthritis or ankylosing spondylitis.
- Current participation in structured neck/shoulder rehabilitation programs.
- Uncontrolled medical conditions contraindicating exercise, e.g., uncontrolled hypertension or cardiovascular disease.
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci
|
Deep cervical flexor training will be performed using a pressure biofeedback unit to facilitate selective activation and improve the strength and endurance of the deep cervical flexor muscles, particularly the longus colli and longus capitis.
The participant will be positioned in supine lying with the hips and knees comfortably flexed, and the pressure biofeedback cuff will be placed beneath the cervical spine at approximately the C4-C5 level.
The cuff will be inflated to a baseline pressure of 20 mmHg.
The participant will be instructed to perform a gentle cranio-cervical flexion movement by slowly nodding the head and drawing the chin inward while maintaining contact of the head with the treatment surface.
The pressure will be gradually increased to the prescribed target while avoiding head lifting, excessive cervical flexion, jaw clenching, shoulder elevation, or compensatory activation of the superficial cervical muscles.
The target pressure will be 22 mmHg during the first week, 2
Scapular stabilization exercises will be performed progressively to improve scapular control, postural alignment, and the strength and endurance of the scapular stabilizing muscles.
During the first week, scapular retraction and depression exercises will be performed in sitting for 3 sets of 10 repetitions with a 5-second hold and 60 seconds rest between sets.
During the second week, scapular retraction will be progressed using light TheraBand resistance for 3 sets of 10 repetitions with controlled movement and 60 seconds rest between sets.
During the third week, wall slides and prone Y and T raises will be introduced and performed for 3 sets of 8-10 repetitions with controlled movement and 30-60 seconds rest between sets.
During the fourth week, scapular stabilization exercises will be progressed with shoulder flexion and abduction while maintaining appropriate scapular control, performed for 3 sets of 10 repetitions with 30-60 seconds rest between sets.
All exercises will be performe
Standard physiotherapy will include therapeutic exercises and postural management techniques aimed at reducing pain, improving cervical mobility, flexibility, and functional performance.
Cervical range-of-motion exercises including flexion, extension, lateral flexion, and rotation will be performed within a pain-free range for 10 repetitions in each direction.
Stretching exercises for the upper trapezius, levator scapulae, and pectoral muscles will be performed for 20-30 seconds for 3 repetitions.
Cervical isometric strengthening exercises including flexion, extension, and lateral flexion will be performed with a 5-10-second hold for 10 repetitions.
Postural education and ergonomic advice will also be provided, including instructions regarding proper sitting posture, appropriate head and neck positioning, and avoidance of prolonged static postures.
Standard physiotherapy will be provided for approximately 10-15 minutes per session, three times weekly for four consecutive weeks.
|
|
Comparador activo: Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy
|
Deep cervical flexor training will be performed using a pressure biofeedback unit to facilitate selective activation and improve the strength and endurance of the deep cervical flexor muscles, particularly the longus colli and longus capitis.
The participant will be positioned in supine lying with the hips and knees comfortably flexed, and the pressure biofeedback cuff will be placed beneath the cervical spine at approximately the C4-C5 level.
The cuff will be inflated to a baseline pressure of 20 mmHg.
The participant will be instructed to perform a gentle cranio-cervical flexion movement by slowly nodding the head and drawing the chin inward while maintaining contact of the head with the treatment surface.
The pressure will be gradually increased to the prescribed target while avoiding head lifting, excessive cervical flexion, jaw clenching, shoulder elevation, or compensatory activation of the superficial cervical muscles.
The target pressure will be 22 mmHg during the first week, 2
Standard physiotherapy will include therapeutic exercises and postural management techniques aimed at reducing pain, improving cervical mobility, flexibility, and functional performance.
Cervical range-of-motion exercises including flexion, extension, lateral flexion, and rotation will be performed within a pain-free range for 10 repetitions in each direction.
Stretching exercises for the upper trapezius, levator scapulae, and pectoral muscles will be performed for 20-30 seconds for 3 repetitions.
Cervical isometric strengthening exercises including flexion, extension, and lateral flexion will be performed with a 5-10-second hold for 10 repetitions.
Postural education and ergonomic advice will also be provided, including instructions regarding proper sitting posture, appropriate head and neck positioning, and avoidance of prolonged static postures.
Standard physiotherapy will be provided for approximately 10-15 minutes per session, three times weekly for four consecutive weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Neck Disability - Neck Disability Index (NDI)
Periodo de tiempo: Baseline and after 4 weeks of treatment.
|
Measure: Functional disability related to neck pain measured using the Neck Disability Index.
|
Baseline and after 4 weeks of treatment.
|
|
Pain Intensity - Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: Baseline and after 4 weeks of treatment
|
Neck pain intensity measured using the 0-10 Numeric Pain Rating Scale
|
Baseline and after 4 weeks of treatment
|
|
Universal Goniometer
Periodo de tiempo: Baseline and after 4 weeks of treatment.
|
Measure Cervical Range of Motion - Cervical flexion, extension, right/left lateral flexion and right/left rotation
|
Baseline and after 4 weeks of treatment.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Neck Flexor Endurance Test
Periodo de tiempo: Baseline and after 4 weeks of treatment
|
Measure cervical flexor muscle endurance
|
Baseline and after 4 weeks of treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- • Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: a systematic review and meta-analysis. Musculoskeletal Science and Practice. 2020;50:102220. • Saleh MSM, Rehab NI, Sharaf MAF. Effect of deep cervical flexors training on neck proprioception, pain, muscle strength and dizziness in patients with cervical spondylosis: A randomized controlled trial. Phys Ther Rehabil. 2018;5(1):14. • Fatima I, Ashraf A, Khalid K. Effectiveness of thoracic manipulation versus scapular stabilization exercises on pain and functional disability in cervical spondylosis. Journal of Nursing and Allied Health. 2024;2(01). • Ashfaq R, Riaz H. Effect of Pressure biofeedback training on deep cervical flexors endurance in patients with mechanical neck pain: A randomized controlled trial. Pakistan Journal of Medical Sciences. 2021;37(2):550. • Modarresi S, et al. A systematic review and synthesis of psychometric properties of the numeric pain rating scale and the visual analog scale for use in people with neck pain. The Clinical Journal of Pain. 2022;38(2):132-148.
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)
3 de junio de 2026
Finalización primaria (Estimado)
15 de septiembre de 2026
Finalización del estudio (Estimado)
24 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de septiembre de 2026
Publicado por primera vez (Actual)
11 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIUI/RERC/ADT/2026/06/342
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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. .