- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07567300
Common Pain Mechanisms in Migraine, Migraine-Related Neck Pain, and Lower Back Pain: A Cross Sectional Study
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.
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Dilara ONAN, PhD
- Telefonní číslo: +905358642234
- E-mail: dilaraonan@gmail.com
Studijní záloha kontaktů
- Jméno: Pelin YENİLMEZ YEŞİLDAŞ, Neurologist
- Telefonní číslo: +905392040612
- E-mail: pelinnyenilmez@gmail.com
Studijní místa
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Merkez
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Gaziantep, Merkez, Turecko (Türkiye)
- Nábor
- Gazi University
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Kontakt:
- Pelin Yenilmez Yeşildaş, Neurologist
- Telefonní číslo: 05392040612
- E-mail: pelinnyenilmez@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Migréna s epizodickým průběhem
Epizodická migréna je neurologické onemocnění charakterizované opakujícími se středně těžkými až těžkými bolestmi hlavy, které se vyskytují méně než 15 dní v měsíci.\nAtaky obvykle trvají 4 až 72 hodin a jsou často doprovázeny nevolností, zvracením a citlivostí na světlo/zvuk.\nLéčba zahrnuje akutní léky užívané podle potřeby a preventivní strategie ke snížení frekvence záchvatů.
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Chronická migréna
Chronická migréna je definována jako 15 nebo více dní s bolestí hlavy za měsíc po dobu delší než tři měsíce, přičemž alespoň osm z těchto dní splňuje kritéria migrény.
Mezi příznaky patří středně silná až silná pulzující bolest, nevolnost, zvracení a extrémní citlivost na světlo, zvuk nebo pachy.
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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.
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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.
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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.
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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.
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Central Sensitization Inventory
Časové okno: Day 1
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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.
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Day 1
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Headache Intensity
Časové okno: Day 1
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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".
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Day 1
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Headache Impact
Časové okno: Day 1
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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).
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Day 1
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Disability for Migraine
Časové okno: Day 1
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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).
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Day 1
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Disability of the Neck
Časové okno: Day 1
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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.
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Day 1
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Disability of the Lower Back
Časové okno: Day 1
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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.
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Day 1
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Pain Catastrophizing
Časové okno: Day 1
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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."
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Day 1
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Anxiety and Depression
Časové okno: Day 1
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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.
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Day 1
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Headache Awareness
Časové okno: Day 1
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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.
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Day 1
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Neck Awareness
Časové okno: Day 1
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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.
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Day 1
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Back Awareness
Časové okno: Day 1
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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.
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Day 1
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Pressure Pain Threshold Assessment
Časové okno: Day 1
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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.
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Day 1
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Allodynia
Časové okno: Day 1
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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.
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Day 1
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Demographic and Clinic Evaluations
Časové okno: Day 1
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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.
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Day 1
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Dilara Onan, PhD, Yozgat Bozok University
- Studijní židle: Merve Ceren Akgör, Neurologist, Department of Neurology, University of Health Sciences, Ankara Atatürk Sanatorium Training and Research Hospital, Ankara, Türkiye
- Studijní židle: Doğan Porsnok, PhD, Bingol University
- Studijní židle: Pelin Yenilmez Yeşildaş, Neurologist, Gaziantep City Hospital, Department of Neurology
Publikace a užitečné odkazy
Obecné publikace
- Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
- 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.
- 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.
- 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.
- 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.
- 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.
- Ji RR, Nackley A, Huh Y, Terrando N, Maixner W. Neuroinflammation and Central Sensitization in Chronic and Widespread Pain. Anesthesiology. 2018 Aug;129(2):343-366. doi: 10.1097/ALN.0000000000002130.
- 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.
- 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.
- Suzuki K, Suzuki S, Shiina T, Kobayashi S, Hirata K. Central Sensitization in Migraine: A Narrative Review. J Pain Res. 2022 Sep 7;15:2673-2682. doi: 10.2147/JPR.S329280. eCollection 2022.
- 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.
- 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.
- Aydemir, O., Hastane anksiyete ve depresyon olcegi Turkce formunun gecerlilik ve guvenilirligi. Turk Psikiyatri Derg., 1997. 8: p. 187-280.
- 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.
- 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.
- 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.
- 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.
- 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.
- Vivekanantham A, Edwin C, Pincus T, Matharu M, Parsons H, Underwood M. The association between headache and low back pain: a systematic review. J Headache Pain. 2019 Jul 15;20(1):82. doi: 10.1186/s10194-019-1031-y.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Approval No: 3/9; 02.04.2026
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