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Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache

20 augustus 2026 bijgewerkt door: 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):

  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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

32

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Manual Therapy Protocol
Upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the cervical region.
Actieve vergelijker: 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.
Ander: Multicomponent Exercise Program
Deep cervical flexor strengthening, cervical proprioception exercises, gaze stability/head-eye coordination training, and progressive balance exercises.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline Pain Intensity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline Suboccipital Muscle Thickness
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pamukkale University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

28 februari 2027

Studie voltooiing (Geschat)

31 maart 2027

Studieregistratiedata

Eerst ingediend

17 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2026

Eerst geplaatst (Werkelijk)

20 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

20 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • E-60116787-020-796732

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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