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Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07776093
Enrollment
32
Registered
2026-08-20
Start date
2026-09-01
Completion date
2027-03-31
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervicogenic Headache, Proprioceptive Disorders, Neck Pain Musculoskeletal

Brief 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.

Interventions

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

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

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

This study will employ a double-blind design. Participants will be masked regarding their group allocation (manual therapy vs. multicomponent exercise). All baseline and post-intervention outcome assessments will be conducted by an independent outcome assessor who will be fully blinded to the participants' group assignments and intervention protocols. The student physiotherapists administering the treatment protocols will be blinded to all evaluation and assessment results to prevent operator bias.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Migraine Disability Assessment ScoreBaseline 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 ScoreBaseline and Post-intervention at 4 WeeksEvaluated 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).
Change from Baseline Pain IntensityBaseline 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 ScoreBaseline and Post-intervention at 4 WeeksAssessed 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 ScoreBaseline and Post-intervention at Week 4Evaluated using the Tampa Scale for Kinesiophobia (TSK) 4-point Likert scale (17-68 score range) to measure fear of movement and re-injury.

Secondary

MeasureTime frameDescription
Change from Baseline Deep Cervical Flexor Muscle EnduranceBaseline 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 ScoreBaseline and Post-intervention at Week 4Measured 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 MotionBaseline and Post-intervention at 4 WeeksEvaluated 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.
Change from Baseline Suboccipital Muscle ThicknessBaseline and Post-intervention at 4 WeeksEvaluated 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 ErrorBaseline and Post-intervention at 4 WeeksEvaluated 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 ScoreBaseline and Post-intervention at Week 4Evaluated using the Head-Eye Movements Control Test, scored as 0 (negative/stable), 1 (moderately positive), or 2 (strongly positive/unstable).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026