NCT07567300

Brief 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. 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 22, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2026

Expected
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

April 22, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

migraineneck painlow back paincentral sensitizationpain threshold

Outcome Measures

Primary Outcomes (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.

    Day 1

Secondary Outcomes (13)

  • Headache Intensity

    Day 1

  • Disability for Migraine

    Day 1

  • Disability of the Neck

    Day 1

  • Disability of the Lower Back

    Day 1

  • Headache Impact

    Day 1

  • +8 more secondary outcomes

Study Arms (8)

Episodic migraine

Episodic 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 pain

Episodic 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 pain

Episodic 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 pain

Episodic 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 migraine

Chronic 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 pain

Chronic 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 pain

Chronic 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 pain

Chronic 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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Gaziantep City Hospital, Department of Neurology, Gaziantep, Türkiye.

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • Yalin OÖ, Uludüz D, Sungur MA, Sart H, Özge 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. PMID: 29033640; PMCID: PMC5630106.

    BACKGROUND
  • Castien, R.F., et al., 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. 22(1): p. 69.

    BACKGROUND
  • Erol, E., et al., Reliability and Validity of the Turkish Version of the Fremantle Back Awareness Questionnaire. Spine (Phila Pa 1976), 2019. 44(9): p. E549-e554.

    BACKGROUND
  • Onan, D., D. Gokmen, and O. Ulger, The Fremantle Neck Awareness Questionnaire in Chronic Neck Pain Patients: Turkish Version, Validity and Reliability Study. Spine (Phila Pa 1976), 2020. 45(3): p. E163-e169.

    BACKGROUND
  • Onan, D., et al., Assessment of Head Awareness in Patients with Chronic Migraine Using the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity, and Reliability Study. Noro Psikiyatr Ars, 2026. 63: p. 308-315.

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

    BACKGROUND
  • Yakut, E., et al., Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976), 2004. 29(5): p. 581-5; discussion 585.

    BACKGROUND
  • Aslan, E., et al., The cultural adaptation, reliability and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976), 2008. 33(11): p. E362-5.

    BACKGROUND
  • 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.

    BACKGROUND
  • Düzce Keleş, E., et al., Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol, 2021. 36(4): p. 518-526.

    BACKGROUND
  • Ertaş, M., et al., Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire. Headache, 2004. 44(8): p. 786-93.

    BACKGROUND
  • Börner-Schröder, C., et al., 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. 17: p. 11795735251404279.

    BACKGROUND
  • Al-Khazali, H.M., et al., Prevalence of neck pain in migraine: A systematic review and meta-analysis. Cephalalgia, 2022. 42(7): p. 663-673.

    BACKGROUND
  • Al-Khazali, H.M., et al., Neck pain and headache: Pathophysiology, treatments and future directions. Musculoskelet Sci Pract, 2023. 66: p. 102804.

    BACKGROUND
  • Yoon, M.S., et al., Chronic migraine and chronic tension-type headache are associated with concomitant low back pain: results of the German Headache Consortium study. Pain, 2013. 154(3): p. 484-492.

    BACKGROUND
  • Vivekanantham, A., et al., The association between headache and low back pain: a systematic review. J Headache Pain, 2019. 20(1): p. 82.

    BACKGROUND
  • Ji, R.R., et al., Neuroinflammation and Central Sensitization in Chronic and Widespread Pain. Anesthesiology, 2018. 129(2): p. 343-366.

    BACKGROUND
  • Woolf, C.J., Central sensitization: implications for the diagnosis and treatment of pain. Pain, 2011. 152(3 Suppl): p. S2-s15.

    BACKGROUND
  • Suzuki, K., et al., Central Sensitization in Migraine: A Narrative Review. J Pain Res, 2022. 15: p. 2673-2682.

    BACKGROUND

MeSH Terms

Conditions

Neck PainMigraine DisordersLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBack Pain

Study Officials

  • Merve Ceren Akgör, Neurologist

    Department of Neurology, University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital, Ankara, Türkiye

    STUDY CHAIR
  • Doğan Porsnok, PhD

    Bingol University

    STUDY CHAIR
  • Pelin Yenilmez Yeşildaş, Neurologist

    Gaziantep City Hospital, Department of Neurology

    STUDY CHAIR
  • Dilara Onan, PhD

    Yozgat Bozok University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilara ONAN, PhD

CONTACT

Pelin YENİLMEZ YEŞİLDAŞ, Neurologist

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 5, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

June 17, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 5, 2026

Record last verified: 2026-05