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Neck PainNCT07567300

Common Pain Mechanisms in Migraine, Migraine-Related Neck Pain, and Lower Back Pain: A Cross Sectional Study

An observational study of Neck Pain and Migraine, run by Bozok University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Migraine is one of the primary headache disorders with a high prevalence worldwide, leading to significant disability and reduced quality of life. Trigeminal nerve activation and alterations in central pain processing mechanisms play a crucial role in the pathophysiology of migraine. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Neck Pain, Migraine, Low Back Pain
How many people
179 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Apr 2026to 30 Nov 2026
How long will I take part?
1 Day
Phase
Observational
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 65 years
  • All sexes
  • Adult, Older adult

Study population: Gaziantep City Hospital, Department of Neurology, Gaziantep, Türkiye.

Who may be able to join

  • Being between 18 and 65 years of age,
  • Being able to read and understand Turkish,
  • Agreeing to participate voluntarily,
  • Having an episodic or chronic migraine diagnosis according to the International Classification of Headache Disorders Edition 3 criteria;
  • Having neck pain and/or lower back pain without any underlying diagnosis accompanying the migraine diagnosis.

Who cannot join

  • A history of neurological disorder (e.g., Multiple Sclerosis),
  • Inflammatory rheumatic disorders (e.g., Rheumatoid Arthritis), generalized chronic pain syndromes (e.g., Fibromyalgia),
  • Any other headache disease, any other systemic disease,
  • Acute fracture and infection,
  • Spinal surgery or spinal disease diagnosis within the last 6 months,
  • Serious musculoskeletal trauma within the last 6 months,
Show all 10Show fewer
  • Pregnancy,
  • A cognitive or psychiatric condition that would prevent completion of the questionnaires,
  • In the control group without a migraine diagnosis,
  • A history of recurrent headaches within the last year.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dilara ONAN, PhD contact

+905358642234

dilaraonan@gmail.com

Pelin YENİLMEZ YEŞİLDAŞ, Neurologist contact

+905392040612

pelinnyenilmez@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Gazi University

    Gaziantep, Merkez

    Pelin Yenilmez Yeşildaş, Neurologist, 05392040612, pelinnyenilmez@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: From Mechanisms to Clinical Evidence: A Cross-Sectional Study of Common Pain Mechanisms in Migraine, Migraine-Related Neck Pain, and Lower Back Pain

Migraine is one of the primary headache disorders with a high prevalence worldwide, leading to significant disability and reduced quality of life. Trigeminal nerve activation and alterations in central pain processing mechanisms play a crucial role in the pathophysiology of migraine. Recent studies suggest that migraine may not only be a headache disorder but also a systemic pain disorder associated with changes in central pain processing mechanisms. Central sensitization is defined as increased sensitivity of nociceptive neurons in the central nervous system to afferent stimuli and is considered a key mechanism in the development and maintenance of chronic pain conditions. This condition is characterized by pain hypersensitivity, allodynia, and generalized pain sensitivity.

In addition to headaches, other musculoskeletal pains are also frequently reported in migraine patients. Spinal pain, particularly neck and lower back pain, can occur in migraine sufferers, with central sensitization contributing to the condition, considering the spine as a chain. Large population-based studies have shown a significant association between primary headaches and persistent low back pain, and a higher prevalence of concomitant low back pain has been reported in individuals with chronic migraine and chronic tension-type headaches. This association is suggested to be explained by the shared nociceptive pathways of the head and spinal structures and the changes in central pain processing seen in chronic pain conditions.

Read more

This relationship between migraine and musculoskeletal pain is also explained by the presence of shared neuroanatomical structures such as the trigemino-cervical complex. Nociceptive afferents from the upper cervical spine and cranial structures converge at the trigemino-cervical complex level in the brainstem, creating a predisposition to the co-occurrence of head and neck pain. This mechanism suggests that pain or dysfunction in the cervical region in migraine patients may be related to headache symptoms. Studies have shown that neck pain is more common in individuals with migraine than in the general population, and research suggests this rate may be approximately 10-12 times higher compared to healthy individuals. Furthermore, it has been reported that individuals with migraine more frequently experience tenderness in cranio-cervical muscles such as the upper trapezius, sternocleidomastoid, and suboccipital muscles, myofascial trigger points, and increased muscle sensitivity. The literature also emphasizes that these cervical symptoms may be related to migraine frequency, attack severity, and headache-related disability.

These findings suggest that migraine should be considered not only as a primary headache disorder but also as a complex neurobiological condition associated with widespread pain sensitivity and musculoskeletal symptoms. A better understanding of the relationship between migraine and musculoskeletal pain could be important for developing multidisciplinary treatment approaches. However, clinical studies in the literature that evaluate migraine, accompanying neck pain, and lower back pain together in terms of common pain mechanisms are quite limited. Therefore, the rationale for this study is that examining factors such as central sensitization, pain threshold, pain catastrophizing, psychological factors, body awareness, and regional disability together in migraine patients can lead to a better understanding of the pathophysiology of migraine-related musculoskeletal pain. Based on all these reasons and evidence, the aim of this study is to investigate the possible common pain mechanisms and musculoskeletal pathophysiological processes of migraine-related neck and back pain in migraine patients with accompanying neck and/or back pain by evaluating factors such as central sensitization, pain threshold, pain catastrophizing, psychological factors, body awareness, and regional disability together.

Keywords
migraine, neck pain, low back pain, central sensitization, pain threshold
Medical subject headings
Neck Pain, Migraine Disorders, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07567300
Study groupRoleWhat they receive
Episodic migraineEpisodic migraine is a neurological condition characterized by recurrent, moderate-to-severe headaches occurring on fewer than 15 days per month. Attacks typically last 4 to 72 hours and are often accompanied by nausea, vomiting, and light/sound sensitivity. Treatment involves acute, on-demand medication and preventative strategies to reduce attack frequency.
Episodic migraine with neck painEpisodic migraine is a neurological condition characterized by recurrent, moderate-to-severe headaches occurring on fewer than 15 days per month. Attacks typically last 4 to 72 hours and are often accompanied by nausea, vomiting, and light/sound sensitivity. Treatment involves acute, on-demand medication and preventative strategies to reduce attack frequency. Additionally, this sample includes individuals diagnosed with episodic migraine and experiencing neck pain without having any other diagnosed neck problems.
Episodic migraine with low back painEpisodic migraine is a neurological condition characterized by recurrent, moderate-to-severe headaches occurring on fewer than 15 days per month. Attacks typically last 4 to 72 hours and are often accompanied by nausea, vomiting, and light/sound sensitivity. Treatment involves acute, on-demand medication and preventative strategies to reduce attack frequency. Additionally, this sample includes individuals diagnosed with episodic migraine and experiencing low back pain without having any other diagnosed lower back problems.
Episodic migraine with neck pain and low back painEpisodic migraine is a neurological condition characterized by recurrent, moderate-to-severe headaches occurring on fewer than 15 days per month. Attacks typically last 4 to 72 hours and are often accompanied by nausea, vomiting, and light/sound sensitivity. Treatment involves acute, on-demand medication and preventative strategies to reduce attack frequency. Additionally, this sample includes individuals diagnosed with episodic migraine and experiencing neck pain and low back pain without having any other diagnosed neck and lower back problems.
Chronic migraineChronic migraine is defined by having 15 or more headache days per month for over three months, with at least eight of those days meeting migraine criteria. Symptoms include moderate-to-severe throbbing pain, nausea, vomiting, and extreme sensitivity to light, sound, or smell.
Chronic migraine with neck painChronic migraine is defined by having 15 or more headache days per month for over three months, with at least eight of those days meeting migraine criteria. Symptoms include moderate-to-severe throbbing pain, nausea, vomiting, and extreme sensitivity to light, sound, or smell. Additionally, this sample includes individuals diagnosed with chronic migraine and experiencing neck pain without having any other diagnosed neck problems.
Chronic migraine with low back painChronic migraine is defined by having 15 or more headache days per month for over three months, with at least eight of those days meeting migraine criteria. Symptoms include moderate-to-severe throbbing pain, nausea, vomiting, and extreme sensitivity to light, sound, or smell. Additionally, this sample includes individuals diagnosed with chronic migraine and experiencing low back pain without having any other diagnosed lower back problems.
Chronic migraine with neck pain and low back painChronic migraine is defined by having 15 or more headache days per month for over three months, with at least eight of those days meeting migraine criteria. Symptoms include moderate-to-severe throbbing pain, nausea, vomiting, and extreme sensitivity to light, sound, or smell. Additionally, this sample includes individuals diagnosed with chronic migraine and experiencing neck pain and low back pain without having any other diagnosed neck and lower back problems.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central Sensitization Inventory

    The Central Sensitization Inventory (CSI) measures somatic and emotional symptoms common in central sensitization syndrome. Section A measures 25 symptoms with 5 response options (0 to 4). The total score ranges from 0 to 100. Section B asks patients whether they have previously been diagnosed with preliminary specific CSI conditions.

    Measured: Day 1

Secondary outcomes (13)
  1. Headache Intensity

    The Numerical Pain Rating Scale (NPRS) consists of pain levels where the person indicates the pain they are currently experiencing with a vertical line on a plane. The pain felt by the person is given on a scale of 0-10, "0: no pain", "10: I feel very severe pain".

    Measured: Day 1

  2. Disability for Migraine

    The Migraine Disability Assessment (MIDAS) questionnaire evaluates the last 3 months of disability and consists of a 5-item self-administered test covering disability at work/school, household chores, family and social or leisure activities. The total number of days missed in these activities is the total score and classifies the disability as minimal disability (0-5 points), mild disability (6-10 points), moderate disability (11-20 points), or severe disability (≥21).

    Measured: Day 1

  3. Disability of the Neck

    The Neck Disability Index includes a total of 10 questions covering topics such as pain, personal care, concentration, work, driving, and sleeping. Each question is scored on a scale of 0 to 5 points. The questionnaire is graded out of a maximum of 50 points. A score of "0" means no limitations, while a score of "50" means a complete disability.

    Measured: Day 1

  4. Disability of the Lower Back

    The Oswestry Disability Index consists of 10 questions that assess the extent to which back pain affects various daily living activities such as sitting, personal care (dressing, bathing, etc.), standing, walking, sleeping, and traveling. Each question is scored on a scale of 0-5, with a total score of 0-100. Higher scores indicate a higher level of functional disability.

    Measured: Day 1

  5. Headache Impact

    The Headache Impact Test-6 (HIT-6) is a questionnaire for headaches that assesses vitality, pain, psychological distress, sociability, role, and cognitive functioning. Each item is scored on a 5-point Likert scale (6=never, 8=rarely, 10=sometimes, 11=very often, 13=always). The total score is determined by summing the scores on all six items and ranges from 36 to 78 points. (≤49 = little/no impact, 50-55 = some impact, 56-59 = significant impact, and 60-78 = serious impact).

    Measured: Day 1

  6. Pain Catastrophizing

    The Pain Catastrophizing Scale is a 13-item scale that assesses negative thoughts and feelings related to experienced pain. Each item is scored between 0-never and 4-always. The total score ranges from 0-52, with higher scores indicating a higher level of pain catastrophizing. The scale consists of subscales of "Helplessness, Magnification, and Rumination."

    Measured: Day 1

  7. Anxiety and Depression

    The Hospital Anxiety and Depression Scale (HADS) consists of 14 items; 7 items assess anxiety symptoms and 7 items assess depression symptoms. Each item is scored between 0 and 3 points. By summing the subscale scores, a score of 0-21 can be obtained for each of the Depression and Anxiety subscales. For each subscale, a score of 0-7 is considered the normal range, a score of 8-10 suggests the presence of a mood disorder, and a score of 11 or higher indicates a possible mood disorder.

    Measured: Day 1

  8. Headache Awareness

    The Fremantle Headache Awareness Questionnaire (FHAQ) is a Likert-type questionnaire (0=Never/Never feel like this, 1=Rarely feel like this, 2=Sometimes or occasionally feel like this, 3=Frequently feel like this, 4=Always or most of the time) that assesses altered perceptions related to headache in an individual. The questionnaire asks individuals nine questions, including how they perceive their head relative to their body and how they perceive their body position when experiencing a headache.

    Measured: Day 1

  9. Neck Awareness

    The Fremantle Neck Awareness Questionnaire (FreNAQ) is a Likert-type questionnaire (0=Never/Never feel like this, 1=Rarely feel like this, 2=Sometimes or occasionally feel like this, 3=Frequently feel like this, 4=Always or most of the time) that assesses an individual's perception of altered neck-specific sensations. The questionnaire asks nine questions, including how individuals perceive their neck relative to their body and how they perceive their body position.

    Measured: Day 1

  10. Back Awareness

    The Fremantle Back Awareness Questionnaire (FBAQ) is a Likert-type questionnaire (0=Never/Never feel like this, 1=Rarely feel like this, 2=Sometimes, or occasionally feel like this, 3=Frequently feel like this, 4=Always or most of the time) that assesses an individual's altered perception of their waist. The questionnaire asks individuals nine questions, including how they perceive their waist relative to their body and how they perceive their body position.

    Measured: Day 1

  11. Pressure Pain Threshold Assessment

    Pressure pain threshold measurements will be performed using an analog algometer to objectively assess pain sensitivity. The pressure pain threshold is defined as the pressure value at which an individual first reports a sensation of pain during mechanical pressure application, and it is a reliable and widely used method in the assessment of musculoskeletal pain and central sensitization. Measurements will be performed bilaterally over the temporalis muscle, superior trapezius muscle, suboccipital muscles, and lumbar paraspinal muscles to assess migraine-related pain sensitivity and possible generalized sensitivity. The analog algometer probe will be placed perpendicular to the measurement point, and the pressure will be increased gradually. Participants will be asked to report their first sensation of pain, and the value at this point will be recorded. Three repetitions will be performed for each measurement point, and the average value will be used in the analyses.

    Measured: Day 1

  12. Allodynia

    The "Allodynia Symptom Checklist (ASC-12)" is a 12-item questionnaire where zero points are awarded for "Not applicable to me," "Never," and "Rarely," one point for "Less than half," and two points for "More than half." Total scores range from "0" to "24." Allodynia levels are determined as follows: 0-2 points: none, 3-5 points: mild, 6-8 points: moderate, 9 and above: severe.

    Measured: Day 1

  13. Demographic and Clinic Evaluations

    Demographic and clinical information such as sex, age, weight, height, education level, occupation, medical history, family history, number of years diagnosed with migraine (if any), migraine triggers, symptoms experienced during attacks, number of headache days per month, number of headache attacks per month, duration of attacks, and localization of headaches will be recorded for all patients.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start30 Apr 2026
  3. Primary completion17 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
179 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07567300
Sponsor's protocol ID
Approval No: 3/9; 02.04.2026
Status last verified
Sep 2026
First submitted
22 Apr 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

Publications

  • Yalin OO, Uluduz D, Sungur MA, Sart H, Ozge A. Identification of Allodynic Migraine Patients with the Turkish Version of the Allodynia Symptom Checklist: Reliability and Consistency Study. Noro Psikiyatr Ars. 2017 Sep;54(3):260-266. doi: 10.5152/npa.2016.15953. Epub 2016 Apr 15.

    PubMed 29033640
  • Castien RF, Coppieters MW, Durge TSC, Scholten-Peeters GGM. High concurrent validity between digital and analogue algometers to measure pressure pain thresholds in healthy participants and people with migraine: a cross-sectional study. J Headache Pain. 2021 Jul 12;22(1):69. doi: 10.1186/s10194-021-01278-8.

    PubMed 34253164
  • Erol E, Yildiz A, Yildiz R, Apaydin U, Gokmen D, Elbasan B. Reliability and Validity of the Turkish Version of the Fremantle Back Awareness Questionnaire. Spine (Phila Pa 1976). 2019 May 1;44(9):E549-E554. doi: 10.1097/BRS.0000000000002909.

    PubMed 30325886
  • Onan D, Gokmen D, Ulger O. The Fremantle Neck Awareness Questionnaire in Chronic Neck Pain Patients: Turkish Version, Validity and Reliability Study. Spine (Phila Pa 1976). 2020 Feb 1;45(3):E163-E169. doi: 10.1097/BRS.0000000000003207.

    PubMed 31425430
  • Onan D, Arikan H, Vuralli D, Akgor MC, Pala AB, Yanik E, Can AI, Ulutas C, Yesildas PY, Yildirim I, Gelener P, Demirel EA, Ekizoglu E, Ozge A. Assessment of Head Awareness in Patients with Chronic Migraine Using the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity, and Reliability Study. Noro Psikiyatr Ars. 2025 Sep 19;63:308-315. doi: 10.29399/npa.29190. eCollection 2026.

    PubMed 41777502
  • Aydemir, O., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 1997. 8: p. 187-280.

  • Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.

    PubMed 15129077
  • Aslan E, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagly N. The cultural adaptation, reliability and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2008 May 15;33(11):E362-5. doi: 10.1097/BRS.0b013e31817144e1.

    PubMed 18469684
  • Ugurlu, M., et al., Validity of Turkish form of Pain Catastrophizing Scale and modeling of the relationship between pain-related disability with pain intensity, cognitive, and emotional factors. Psychiatry and Clinical Psychopharmacology, 2017. 27(2): p. 189-196.

  • Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.

    PubMed 35382371
  • Ertas M, Siva A, Dalkara T, Uzuner N, Dora B, Inan L, Idiman F, Sarica Y, Selcuki D, Sirin H, Oguzhanoglu A, Irkec C, Ozmenoglu M, Ozbenli T, Ozturk M, Saip S, Neyal M, Zarifoglu M; Turkish MIDAS group. Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2004 Sep;44(8):786-93. doi: 10.1111/j.1526-4610.2004.04146.x.

    PubMed 15330825
  • Borner-Schroder C, Lachhammer T, Behrendt P, Pfeifer T, Kolorz P, Lense S, Pompignoli J, Reichert M, Schramm S, Heinen F, Sollmann N, Bonfert MV. The Temporal Associations of Neck Pain and Headache - Implications for the Diagnostic Approach to the Myofascial Involvement in Migraine. J Cent Nerv Syst Dis. 2025 Dec 11;17:11795735251404279. doi: 10.1177/11795735251404279. eCollection 2025.

    PubMed 41394282
  • Al-Khazali HM, Younis S, Al-Sayegh Z, Ashina S, Ashina M, Schytz HW. Prevalence of neck pain in migraine: A systematic review and meta-analysis. Cephalalgia. 2022 Jun;42(7):663-673. doi: 10.1177/03331024211068073. Epub 2022 Feb 15.

    PubMed 35166137
  • Al-Khazali HM, Kroll LS, Ashina H, Melo-Carrillo A, Burstein R, Amin FM, Ashina S. Neck pain and headache: Pathophysiology, treatments and future directions. Musculoskelet Sci Pract. 2023 Aug;66:102804. doi: 10.1016/j.msksp.2023.102804. Epub 2023 Jun 16.

    PubMed 37394323
  • Yoon MS, Manack A, Schramm S, Fritsche G, Obermann M, Diener HC, Moebus S, Katsarava Z. Chronic migraine and chronic tension-type headache are associated with concomitant low back pain: results of the German Headache Consortium study. Pain. 2013 Mar;154(3):484-492. doi: 10.1016/j.pain.2012.12.010. Epub 2012 Dec 28.

    PubMed 23375162

Questions about this trial

What is this clinical trial studying?

An observational study of Neck Pain and Migraine, run by Bozok University at 1 site in Turkey (Türkiye).

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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Dilara ONAN, PhD (+905358642234, dilaraonan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Sensitization Inventory (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567300, which also lists 19 linked publications.

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 1 Oct 2026.

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