Cervicogenic HeadacheNCT07776093
Manual Therapy vs. Multicomponent Exercise in Cervicogenic Headache
A study testing Manual Therapy Protocol and Multicomponent Exercise Program in people with Cervicogenic Headache and Proprioceptive Disorders, run by Pamukkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cervicogenic Headache, Proprioceptive Disorders, Neck Pain Musculoskeletal
- What is being tested?
- Manual Therapy Protocol and Multicomponent Exercise Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
About this study
Official 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
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.
Read more
Participants will be randomly assigned to one of two treatment groups for a duration of 4 weeks (12 sessions total):
- Manual Therapy Group: Receives joint mobilization, myofascial release, trigger point release, and suboccipital distraction targeting the cervical region.
- 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.
- Being tested
- Manual Therapy Protocol, Multicomponent Exercise Program
- Medical subject headings
- Post-Traumatic Headache, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy ProtocolProcedure or surgery
Upper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the cervical region.
Multicomponent Exercise ProgramOther
Deep cervical flexor strengthening, cervical proprioception exercises, gaze stability/head-eye coordination training, and progressive balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Group | Experimental | 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. Receives: Procedure: Manual Therapy Protocol |
| Multicomponent Exercise Group | Active comparator | 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. Receives: Other: Multicomponent Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain Intensity
Evaluated using a 10-cm Visual Analog Scale (VAS) measured in centimeters to assess headache pain intensity.
Measured: Baseline and Post-intervention (Week 4)
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.
Measured: Baseline and Post-intervention at 4 Weeks
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.
Measured: Baseline and Post-intervention at Week 4
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)
Measured: Baseline and Post-intervention at 4 Weeks.
Change from Baseline Neck Disability Index Score
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).
Measured: Baseline and Post-intervention at 4 Weeks
Secondary outcomes (6)
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.
Measured: Baseline and Post-intervention at 4 Weeks
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.
Measured: Baseline and Post-intervention at 4 Weeks
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).
Measured: Baseline and Post-intervention at Week 4
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.
Measured: Baseline and Post-intervention (Week 4).
Change from Baseline Postural Balance Score
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.
Measured: Baseline and Post-intervention at Week 4
Change from Baseline Cervical Range of Motion
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.
Measured: Baseline and Post-intervention at 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borna Farhoomand, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776093
- Sponsor's protocol ID
- E-60116787-020-796732
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07776093
- Acronym / sponsor ID
- E-60116787-020-796732
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Manual Therapy Group: Receives joint mobilization, myofascial release, trigger point release, and suboccipital distraction targeting the cervical region.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Group | Experimental | Procedure: Manual Therapy ProtocolParticipants 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 ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy ProtocolUpper cervical joint mobilization, myofascial release, suboccipital distraction, and trigger point therapy targeting the cervical region. | Procedure or surgery | Manual Therapy Group |
| Multicomponent Exercise ProgramDeep cervical flexor strengthening, cervical proprioception exercises, gaze stability/head-eye coordination training, and progressive balance exercises. | Other | Multicomponent Exercise Group |
Primary outcome
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.
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.
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.
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)
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).
6 secondary outcomes
Change from Baseline Suboccipital Muscle Thickness
Time frame: Baseline and Post-intervention at 4 Weeks
Change from Baseline Cervical Joint Position Sense Error
Time frame: Baseline and Post-intervention at 4 Weeks
Change from Baseline Head-Eye Movement Control Test Score
Time frame: Baseline and Post-intervention at Week 4
Change from Baseline Deep Cervical Flexor Muscle Endurance
Time frame: Baseline and Post-intervention (Week 4).
Change from Baseline Postural Balance Score
Time frame: Baseline and Post-intervention at Week 4
Change from Baseline Cervical Range of Motion
Time frame: Baseline and Post-intervention at 4 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy Protocol and Multicomponent Exercise Program in people with Cervicogenic Headache and Proprioceptive Disorders, run by Pamukkale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pain Intensity (time frame: Baseline and Post-intervention (Week 4)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.