Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache

NCT07776093 — Not applicable, Not yet recruiting, 32 participants, Pamukkale University

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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

Registry	NCT07776093
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	32 (Estimated)
Sponsor	Pamukkale University (Other)
Conditions	Cervicogenic Headache, Proprioceptive Disorders, Neck Pain Musculoskeletal
Interventions	Manual Therapy Protocol, Multicomponent Exercise Program (Procedure, other)
Dates	start 2026-09-01 (estimated), primary completion 2027-02-28 (estimated), completion 2027-03-31 (estimated), first posted 2026-08-20, last updated 2026-08-24

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Manual Therapy Group	Experimental	Procedure: Manual Therapy Protocol	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.
Multicomponent Exercise Group	Active comparator	Other: Multicomponent Exercise Program	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.

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.

+Outcome measures

Primary outcomes

Change from Baseline Pain Intensity [Baseline and Post-intervention (Week 4)]: Evaluated using a 10-cm Visual Analog Scale (VAS) measured in centimeters to assess headache pain intensity.
Change from Baseline Central Sensitization Inventory Score [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.
Change from Baseline Tampa Scale for Kinesiophobia Score [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.
Change from Baseline Migraine Disability Assessment Score [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)
Change from Baseline Neck Disability Index Score [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

Change from Baseline Suboccipital Muscle Thickness [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.
Change from Baseline Cervical Joint Position Sense Error [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.
Change from Baseline Head-Eye Movement Control Test Score [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).
Change from Baseline Deep Cervical Flexor Muscle Endurance [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.
Change from Baseline Postural Balance Score [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.
Change from Baseline Cervical Range of Motion [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.

+Eligibility

Sex: All, ages: 18 Years to 45 Years

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.