- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07776275
Physical Profile of Cervicogenic Headache: Comparison With Neck Pain and Healthy Controls
A Multidimensional Physical Profile of Cervicogenic Headache: A Cross-Sectional Comparison With Nonspecific Neck Pain and Healthy Controls
The goal of this observational study is to compare physical findings across three adult groups. Cervicogenic headache (CGH) is a headache linked to a problem in the neck. Neck pain may affect posture, muscle function, grip strength, and sensitivity to pressure. Researchers do not know whether CGH has a distinct pattern of these findings.
The main questions are:
- Do posture, grip strength, muscle stiffness, elasticity, and pressure sensitivity differ among the groups?
- Are any differences more closely associated with CGH than with neck pain?
Researchers will compare adults ages 25 through 60. One group will include people with CGH lasting at least three months. Another group will include people with neck pain lasting at least six months. People in the neck pain group will have no headaches. Healthy participants will have no neck pain or headaches.
Researchers will not provide treatment or change participants' usual care. Each participant will complete one study visit lasting about 15 minutes. Participants will:
- Answer short questions about their health and pain
- Stand while researchers measure their head and neck posture
- Squeeze a device that measures grip strength
- Complete brief tests of neck muscle stiffness and elasticity
- Tell researchers when applied pressure first becomes painful
Researchers will compare results across the three groups. The findings may guide future CGH assessment and treatment research.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fatih Bali, PhD.
- Phone Number: +905323937689
- Email: fatihbali@hotmail.com
Study Locations
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Sefaköy
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Istanbul, Sefaköy, Turkey (Türkiye), 34433
- Recruiting
- Medipol Sefaköy Üniversite Hastanesi
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Contact:
- Fatih Bali, PhD.
- Phone Number: +905323937689
- Email: fatihbali@hotmail.com
-
Contact:
- Email: fatihbali@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- Inclusion Criteria:
- Aged 25 to 60 years
- Able to provide written informed consent
- Meeting the criteria for one of the following groups:
- Cervicogenic headache: physician diagnosis according to the International Classification of Headache Disorders, 3rd edition, with symptoms lasting at least 3 months
- Chronic nonspecific neck pain: neck pain lasting at least 6 months without headache
- Healthy control: no neck pain or headache
Exclusion Criteria:
- Receipt of physiotherapy for headache or neck pain during the previous 6 months
- Diagnosis of a headache disorder other than cervicogenic headache, including migraine or tension-type headache, or a diagnosis of trigeminal neuralgia
- History of cervical spine surgery or significant cervical trauma
- Current or previous diagnosis of a tumor or cancer
- Serious cardiovascular, cerebrovascular, hematological, metabolic, neurological, or psychiatric disorder
- Rheumatoid arthritis
- Congenital cervical abnormality
- Cervical spondylolisthesis or cervical instability
- Active infection
- Temporomandibular joint dysfunction
- Dizziness or visual disturbance accompanying headache
- Any clinical red flag suggesting serious cervical pathology
- Pregnancy or breastfeeding
- Upper-extremity injury, surgery, or another condition affecting handgrip strength
- Serious musculoskeletal disorder affecting cervical posture or muscle measurements
- Inability to complete the questionnaire-based or instrument-based assessments
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cervicogenic Headache Group
Adults aged 25-60 years with cervicogenic headache diagnosed by a physician according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), and symptoms lasting at least 3 months.
Participants undergo one questionnaire-based and instrument-based assessment session.
No intervention is assigned.
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Chronic Nonspescific Neck Pain Group
Adults aged 25-60 years with chronic nonspecific neck pain lasting at least 6 months and no headache.
Participants undergo one questionnaire-based and instrument-based assessment session.
No intervention is assigned.
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Healthy Control Group
Adults aged 25-60 years with no neck pain or headaches.
Participants undergo one questionnaire-based and instrument-based assessment session.
No intervention is assigned.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Bilateral Upper Trapezius Muscle Stiffness
Time Frame: During the single assessment session at enrollment
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Upper trapezius muscle stiffness will be assessed bilaterally using the MyotonPRO device.
Three consecutive measurements will be obtained at the midpoint between the C7 spinous process and the lateral border of the acromion.
The mean of the three measurements will be used.
Stiffness will be expressed in newtons per meter (N/m), with higher values indicating greater stiffness.
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During the single assessment session at enrollment
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Bilateral Upper Trapezius Logarithmic Decrement
Time Frame: During the single assessment session at enrollment
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Upper trapezius logarithmic decrement will be assessed bilaterally using the MyotonPRO device at the same standardized measurement site.
Three consecutive measurements will be obtained on each side, and their mean will be used.
Logarithmic decrement is a dimensionless inverse indicator of tissue elasticity, with lower values indicating greater elasticity.
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During the single assessment session at enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Bilateral Handgrip Strength
Time Frame: During the single assessment session at enrollment
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Bilateral handgrip strength will be measured using a Jamar Hydraulic Hand Dynamometer set to the second handle position.
Participants will perform three maximal contractions with each hand in a standardized seated position.
The highest value for each hand will be recorded in kilograms, with higher values indicating greater handgrip strength.
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During the single assessment session at enrollment
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Bilateral Upper Trapezius Pressure Pain Threshold
Time Frame: During the single assessment session at enrollment
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Pressure pain threshold will be measured bilaterally over the upper trapezius using a handheld pressure algometer with a 1-cm² probe.
The measurement site will be the midpoint between the C7 spinous process and the lateral border of the acromion.
Pressure will gradually increase until the participant first reports pain.
Values will be recorded in kg/cm², with higher values indicating a higher pressure pain threshold.
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During the single assessment session at enrollment
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Bilateral Suboccipital Pressure Pain Threshold
Time Frame: During the single assessment session at enrollment
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Pressure pain threshold will be measured bilaterally over the suboccipital region using a handheld pressure algometer with a 1-cm² probe.
The measurement site will be located 2 cm lateral to the C2 spinous process.
Pressure will gradually increase until the participant first reports pain.
Values will be recorded in kg/cm², with higher values indicating a higher pressure pain threshold.
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During the single assessment session at enrollment
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Tragus-to-Wall Distance
Time Frame: During the single assessment session at enrollment
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Tragus-to-wall distance will be measured in millimeters using a tape measure.
Participants will stand with their heels, sacrum, and thoracic spine resting comfortably against a wall while maintaining a natural head position.
The distance between the wall and the tragus will be recorded.
Greater distances indicate greater forward positioning of the head.
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During the single assessment session at enrollment
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Craniovertebral Angle
Time Frame: During the single assessment session at enrollment
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The craniovertebral angle will be measured in degrees using a universal goniometer.
The fulcrum will be positioned over the lateral projection of the C7 spinous process.
The stationary arm will remain parallel to the floor, and the movable arm will point toward the tragus.
Three measurements will be obtained, and their mean will be used.
Smaller angles indicate greater forward head posture.
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During the single assessment session at enrollment
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-50.04-2858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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