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Targeted Cervical Versus Integrated Trunk and Diaphragmatic Muscle Retraining for Chronic Mechanical Neck Pain (INT-CMNP)

1 de julio de 2026 actualizado por: Gulf Medical University

Comparison of Targeted Cervical Versus Integrated Trunk and Diaphragmatic Muscle Retraining on Pain and Disability in Chronic Neck Pain: A Randomized Clinical Trial

Persistent pain, functional disability, cervical motor control deficit, and abnormal posture are associated with chronic mechanical neck pain. This study aimed to evaluate the efficacy of an integrated physiotherapy program of cervical motor control training, lumbopelvic stabilization, diaphragmatic breathing exercises, and pressure biofeedback versus conventional cervical physiotherapy in patients with chronic mechanical neck pain through a randomized controlled trial.

40 eligible participants were randomly assigned to the experimental or control group. The two groups were all given supervised physiotherapy three times a week for 6 weeks plus a standardized home exercise program. The main aim was to investigate the efficacy of the interventions on pain intensity and neck related disability. Secondary outcomes were CROM, DCFE, head position, and patient perceived recovery. Outcome measures were conducted at both baseline and the end of the six-week intervention.

Descripción general del estudio

Descripción detallada

Chronic mechanical neck pain is one of the most prevalent musculoskeletal conditions and is related to ongoing pain, diminished cervical movement, poor neck muscle control, poor posture, and diminished functional ability. Conventional physiotherapy emphasizes the mobility, strengthening, stretching and postural correction of the cervical region. Recent research indicates that cervical motor control, trunk stabilization and respiratory training may be beneficial when integrated into a rehabilitation program, as multiple aspects of spinal stability and motor control can be targeted.

The study was designed as a single center, parallel-group, assessor-blinded randomized controlled trial, to compare the effectiveness of integrated physiotherapy program to conventional cervical physiotherapy in subjects with chronic mechanical neck pain.

Participants were recruited from the outpatient physiotherapy department of Thumbay Physical Therapy and Rehabilitation Hospital, Ajman, UAE, where they met the inclusion criteria for having mechanical neck pain with a duration of at least three months. After obtaining informed consent, participants were allocated by a computer-generated random sequence in a 1:1 ratio to either the experimental or control group, with allocation concealed.

The experimental group received an integrated rehabilitation program that included cervical motor control training with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises and traditional physiotherapy interventions as clinically needed. The control group received conventional cervical physiotherapy which included cervical range of motion exercises, isometric strengthening, stretching, scapulothoracic strengthening, proprioceptive training, postural exercises, and other standard physiotherapy treatment. Both groups underwent supervised treatment three times a week for six weeks and an identical home exercise program during the intervention.

The primary outcome measures included intensity of pain (Numeric Pain Rating Scale [NPRS]) and neck-related disability (Neck Disability Index [NDI]). Secondary outcome measures were the cervical range of motion, deep cervical flexor endurance, craniovertebral angle for head posture and the Global Rating of Change (GROC). Assessment of outcomes was conducted at baseline and at the end of the six-week interventions by an assessor who was not aware of the allocation of the interventions.

This study aimed to evaluate the effectiveness of an integrated physiotherapy approach including cervical motor control training, lumbopelvic stabilization, diaphragmatic breathing exercises, and pressure biofeedback in comparison to a conventional cervical physiotherapy approach for reduction of pain, disability, and cervical function and postural control in patients with chronic mechanical neck pain.

Tipo de estudio

Intervencionista

Inscripción (Actual)

40

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

    • Ajman Emirate
      • Ajman, Ajman Emirate, Emiratos Árabes Unidos
        • Thumbay Physical Therapy & Rehabilitation Hospital

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:

  • Age in the range 18-60 years.
  • CNMP (lasting more than 3 months).
  • NPRS score ≥ 3.
  • Head Impact Test (HIT-6) score < 50.
  • Absence of clinical signs of cervical radiculopathy.
  • Capacity to comprehend study procedures, follow directions for exercising and sign informed consent in writing.
  • Diaphragmatic function impairment by the DNS diaphragm test with asymmetric or inadequate rib expansion laterally, high elevation of upper chest or shoulder girdle and diminished truncal stabilization during inhalation.

Exclusion Criteria:

  • Participants were excluded if they had cervical radiculopathy, cervical myelopathy, previous cervical spine surgery, spinal fracture, inflammatory arthritis, malignancy, neurological disorders, pregnancy, or any other serious spinal pathology that would make it difficult for the participant to participate in the rehabilitation programme. People with cognitive deficits or any medical condition which hampered their safe involvement in the exercise programme were also excluded.

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: Integrated Physiotherapy
Participants were treated with a comprehensive physiotherapy intervention that included cervical motor control exercises with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises, and additional physiotherapy interventions as clinically necessary. Three times per week for 6 weeks. In addition, a standardized home exercise program was performed during the intervention.
Participants were given an integrated physiotherapy program which comprised motor control training for the cervical spine with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises, and a standardized home exercise program. Three treatment sessions per week for six weeks were conducted under supervision.
Comparador activo: Conventional Physiotherapy
All participants underwent conventional cervical physio, which included cervical range of motion exercises, cervical isometric strengthening, upper trapezius and levator scapulae and pectoral muscles stretching, scapulothoracic strengthening, proprioceptive training, postural correction exercises and intermittent cervical traction as clinically indicated. Treatment was given three times a week for 6 weeks. A standardized home exercise program was also performed by the participants during the intervention period.
Conventional cervical physiotherapy included cervical range-of-motion exercises, isometric strengthening, stretching, scapulothoracic strengthening, proprioceptive training, postural exercises, and a standardized home exercise program. Supervised treatment was provided three times per week for six weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Neck Disability
Periodo de tiempo: Baseline and 6 weeks
Neck-related disability will be assessed using the NDI. Higher scores indicate greater disability.
Baseline and 6 weeks
Pain Intensity
Periodo de tiempo: Baseline and 6 weeks
Pain intensity will be assessed using the NPRS. The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate reduced pain intensity.
Baseline and 6 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cervical Range of Motion
Periodo de tiempo: Baseline and 6 weeks
Cervical range of motion will be measured in flexion, extension, rotation, and lateral flexion using standard clinical assessment procedures.
Baseline and 6 weeks
Deep Cervical Flexor Endurance
Periodo de tiempo: Baseline and 6 weeks
Deep cervical flexor muscle endurance will be assessed using a standardized endurance test.
Baseline and 6 weeks
Head Posture
Periodo de tiempo: Baseline and 6 weeks
Forward head posture will be assessed by measuring the craniovertebral angle.
Baseline and 6 weeks
Global Rating of Change
Periodo de tiempo: 6 weeks
Participant-perceived overall improvement will be assessed using the GROC scale.
6 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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)

2 de mayo de 2026

Finalización primaria (Actual)

26 de junio de 2026

Finalización del estudio (Actual)

30 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

1 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2026

Publicado por primera vez (Actual)

8 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

The decision regarding the sharing of de-identified individual participant data has not yet been finalized. Data sharing will be considered after study completion and publication, subject to institutional policies, ethical requirements, participant confidentiality, and applicable data-sharing agreements.

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. .

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