Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPamukkale University
About this 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):
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Manual Therapy Protocol
Procedure/SurgeryUpper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the cervical region.
Multicomponent Exercise Program
Other interventionDeep cervical flexor strengthening, cervical proprioception exercises, gaze stability/head-eye coordination training, and progressive balance exercises.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Manual Therapy GroupExperimental treatment 1 intervention
Group B: Multicomponent Exercise GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline Pain Intensity
Evaluated using a 10-cm Visual Analog Scale (VAS) measured in centimeters to assess headache pain intensity.
Time frame
Baseline and Post-intervention (Week 4)2
Change from Baseline Central Sensitization Inventory Score
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.
Time frame
Baseline and Post-intervention at 4 Weeks3
Change from Baseline Tampa Scale for Kinesiophobia Score
Evaluated using the Tampa Scale for Kinesiophobia (TSK) 4-point Likert scale (17-68 score range) to measure fear of movement and re-injury.
Time frame
Baseline and Post-intervention at Week 44
Change from Baseline Migraine Disability Assessment Score
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)
Time frame
Baseline and Post-intervention at 4 Weeks.Secondary outcomes
1
Change from Baseline Suboccipital Muscle Thickness
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.
Time frame
Baseline and Post-intervention at 4 Weeks2
Change from Baseline Cervical Joint Position Sense Error
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.
Time frame
Baseline and Post-intervention at 4 Weeks3
Change from Baseline Head-Eye Movement Control Test Score
Evaluated using the Head-Eye Movements Control Test, scored as 0 (negative/stable), 1 (moderately positive), or 2 (strongly positive/unstable).
Time frame
Baseline and Post-intervention at Week 44
Change from Baseline Deep Cervical Flexor Muscle Endurance
Assessed in seconds using the Cervical Deep Neck Flexor Muscle Endurance Test in a hook-lying chin tuck position.
Time frame
Baseline and Post-intervention (Week 4).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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