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NCT Number: NCT07776093

Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache

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):

1. Manual Therapy Group: Receives joint mobilization, myofascial release, trigger point release, and suboccipital distraction targeting the cervical region. 2. 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.

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Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Neck Pain Musculoskeletal Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Post-Traumatic Headache Proprioceptive Disorders Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual Therapy Protocol

Procedure

Upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the cervical region.

Multicomponent exercise program

Other

Deep cervical flexor strengthening, cervical proprioception exercises, gaze stability/head-eye coordination training, and progressive balance exercises.

Primary outcomes

  1. Change from Baseline Pain Intensity

    Time frame: Baseline and Post-intervention (Week 4)

    Evaluated using a 10-cm Visual Analog Scale (VAS) measured in centimeters to assess headache pain intensity.

  2. Change from Baseline Central Sensitization Inventory Score

    Time frame: 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.

  3. Change from Baseline Tampa Scale for Kinesiophobia Score

    Time frame: 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.

  4. Change from Baseline Migraine Disability Assessment Score

    Time frame: 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)

  5. Change from Baseline Neck Disability Index Score

    Time frame: 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).

Secondary outcomes

  1. Change from Baseline Suboccipital Muscle Thickness

    Time frame: 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.

  2. Change from Baseline Cervical Joint Position Sense Error

    Time frame: 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.

  3. Change from Baseline Head-Eye Movement Control Test Score

    Time frame: 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).

  4. Change from Baseline Deep Cervical Flexor Muscle Endurance

    Time frame: 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.

  5. Change from Baseline Postural Balance Score

    Time frame: 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.

  6. Change from Baseline Cervical Range of Motion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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