Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache
20 de agosto de 2026 actualizado por: Borna Farhoomand, Pamukkale University
Effects of Manual Therapy Versus Multicomponent Exercise on Sensorimotor Function, Suboccipital Muscle Thickness, and Central Sensitization in Cervicogenic Headache: A Double-Blind Randomized Controlled Trial
The purpose of this study is to compare the effects of manual therapy and a multicomponent exercise program on suboccipital muscle thickness, joint position sense, pain, central sensitization, balance, and kinesiophobia in patients diagnosed with cervicogenic headache.
Cervicogenic headache is a common secondary headache originating from dysfunction in the upper cervical spine. Dysfunction in the deep neck muscles, impaired neck joint awareness, and heightened pain sensitivity (central sensitization) are frequently observed in these patients. While both manual therapy and targeted exercise are used in physiotherapy practice, evidence regarding their direct comparative effects on suboccipital muscle morphology and somatosensory parameters remains limited.
Participants will be randomly assigned to one of two treatment groups for a duration of 4 weeks (12 sessions total):
- Manual Therapy Group: Receives joint mobilization, myofascial release, trigger point release, and suboccipital distraction targeting the cervical region.
- Multicomponent Exercise Group: Receives deep cervical flexor strengthening, cervical proprioception training, head-eye coordination training, and progressive balance exercises.
The main questions the study aims to answer are:
- Do manual therapy and multicomponent exercise improve suboccipital muscle thickness and cervical joint position sense in patients with cervicogenic headache?
- Is there a significant difference between manual therapy and multicomponent exercise in reducing pain intensity, central sensitization, disability, and fear of movement (kinesiophobia)? It is hypothesized that both intervention protocols will yield significant clinical improvements, with specific synergistic adaptations in muscle structure, somatosensory system processing, and pain-related fear.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
32
Fase
- No aplica
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:
- Diagnosis of cervicogenic headache by a specialist physician,
- Aged between 18 and 45 years,
- Ability to read and write (literate),
- Provision of signed informed consent to participate in the study.
Exclusion Criteria:
- History of head or neck surgery,
- History of spinal surgery,
- History of severe cardiac conditions or cardiac surgery that contraindicates exercise,
- History of ongoing or past malignancy,
- Diagnosis of psychiatric disorders,
- Diagnosis of migraine,
- Diagnosis of fibromyalgia,
- Having received medical (except analgesics), physical therapy, or other interventions (e.g., alternative medicine, massage therapy) for cervicogenic headache within the last 6 months,
- Engaging in regular exercise or attending an exercise facility within the last 6 months,
- Experiencing headaches strictly associated with the menstrual period,
- Investigator decision for exclusion based on ethical or clinical grounds,
- Communication problems interfering with evaluation and treatment.
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Manual Therapy Group
Participants in this arm will receive 12 sessions of manual therapy (3 sessions per week for 4 weeks).
Interventions include upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the suboccipital and cervical region.
|
Upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the cervical region.
|
|
Comparador activo: Multicomponent Exercise Group
Participants in this arm will receive 12 sessions of a multicomponent exercise program (3 sessions per week for 4 weeks).
Interventions include deep cervical flexor strengthening, cervical proprioception training, gaze stability/head-eye coordination exercises, and progressive postural balance training.
|
Deep cervical flexor strengthening, cervical proprioception exercises, gaze stability/head-eye coordination training, and progressive balance exercises.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline Pain Intensity
Periodo de tiempo: Baseline and Post-intervention (Week 4)
|
Evaluated using a 10-cm Visual Analog Scale (VAS) measured in centimeters to assess headache pain intensity.
|
Baseline and Post-intervention (Week 4)
|
|
Change from Baseline Central Sensitization Inventory Score
Periodo de tiempo: Baseline and Post-intervention at 4 Weeks
|
Assessed using the 25-item Central Sensitization Inventory (CSI) with a total score ranging from 0 to 100 to evaluate the severity of central sensitization.
|
Baseline and Post-intervention at 4 Weeks
|
|
Change from Baseline Tampa Scale for Kinesiophobia Score
Periodo de tiempo: Baseline and Post-intervention at Week 4
|
Evaluated using the Tampa Scale for Kinesiophobia (TSK) 4-point Likert scale (17-68 score range) to measure fear of movement and re-injury.
|
Baseline and Post-intervention at Week 4
|
|
Change from Baseline Migraine Disability Assessment Score
Periodo de tiempo: Baseline and Post-intervention at 4 Weeks.
|
Assessed using the 5-item Migraine Disability Assessment (MIDAS) questionnaire to evaluate the total number of days with headache-related disability (score range 0 to 21+ for disability severity grades I to IV)
|
Baseline and Post-intervention at 4 Weeks.
|
|
Change from Baseline Neck Disability Index Score
Periodo de tiempo: Baseline and Post-intervention at 4 Weeks
|
Evaluated using the 10-item Neck Disability Index (NDI) questionnaire to measure neck pain-related functional disability (score range 0 to 50, higher scores indicating higher disability).
|
Baseline and Post-intervention at 4 Weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline Suboccipital Muscle Thickness
Periodo de tiempo: Baseline and Post-intervention at 4 Weeks
|
Evaluated using B-mode ultrasonography (9-12 MHz linear probe) to measure the thickness (in millimeters) of the rectus capitis posterior major (RCPM) and obliquus capitis superior (OCS) muscles bilaterally at the C1-C2 level.
|
Baseline and Post-intervention at 4 Weeks
|
|
Change from Baseline Cervical Joint Position Sense Error
Periodo de tiempo: Baseline and Post-intervention at 4 Weeks
|
Evaluated using the Cervical Range of Motion (CROM) device to measure cervical joint position error (in degrees) at target angles set at 65% of the participant's active range of motion.
|
Baseline and Post-intervention at 4 Weeks
|
|
Change from Baseline Head-Eye Movement Control Test Score
Periodo de tiempo: Baseline and Post-intervention at Week 4
|
Evaluated using the Head-Eye Movements Control Test, scored as 0 (negative/stable), 1 (moderately positive), or 2 (strongly positive/unstable).
|
Baseline and Post-intervention at Week 4
|
|
Change from Baseline Deep Cervical Flexor Muscle Endurance
Periodo de tiempo: Baseline and Post-intervention (Week 4).
|
Assessed in seconds using the Cervical Deep Neck Flexor Muscle Endurance Test in a hook-lying chin tuck position.
|
Baseline and Post-intervention (Week 4).
|
|
Change from Baseline Postural Balance Score
Periodo de tiempo: Baseline and Post-intervention at Week 4
|
Measured using the Sway mobile application across five stance positions (feet together, left/right tandem, left/right single-leg) under blindfolded conditions, producing a total balance score from 0 to 100.
|
Baseline and Post-intervention at Week 4
|
|
Change from Baseline Cervical Range of Motion
Periodo de tiempo: Baseline and Post-intervention at 4 Weeks
|
Evaluated using the Baseline CROM Deluxe device to measure active cervical flexion, extension, right/left lateral flexion, and right/left rotation in degrees.
Two trials will be performed for each movement and the arithmetic mean will be analyzed.
|
Baseline and Post-intervention at 4 Weeks
|
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 (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
28 de febrero de 2027
Finalización del estudio (Estimado)
31 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2026
Publicado por primera vez (Actual)
20 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos de dolor de cabeza
- Trastornos sensoriales
- Trastornos de Cefalea, Secundaria
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Trastornos somatosensoriales
- Dolor de cabeza postraumático
Otros números de identificación del estudio
- E-60116787-020-796732
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
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