Clinical trial NCT06857357: Tampa Kinesiophobia Scale Modified for Headache
Official title: Evaluation of Kinesiophobia in Patients with Headache Using the Tampa Kinesiophobia Scale Modified for Headache: Turkish Version, Validity and Reliability Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Migraine
Tension-type Headache
Cervicogenic Headache
Keywords: Migraine
Tension-type headache
Cervicogenic headache
kinesiophobia
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-70 who applied to the Department of Neurology of Mersin University Faculty of Medicine and the Department of Neurology of Gazi University Faculty of Medicine and who were diagnosed with episodic/chronic migraine, tension-type headache and cervicogenic headache according to the International Classification of Headache Disorders, 3rd Edition, by a neurologist who is an expert in the field of headache will be included in the study.

Brief summary: Tampa Kinesiophobia Scale is a scale that has been validated and reliable in individuals with low back pain in the Turkish population and evaluates fear of movement due to the risk of triggering pain. Especially for migraine headache, patients have complaints about movement and fear of movement, and in addition, according to the International Classification of Headache Disorders, 3rd Edition criteria, the item of aggravation with physical activity is considered as a diagnostic criterion. Migraine patients may theoretically start their attacks due to hypocretin neuropeptide and lactate metabolism dysfunction. It has been stated that calcitonin gene-related peptide (CGRP), which is released during migraine attacks, is also released during exercise and intense physical activity and can trigger attacks. Therefore, patients avoid physical activity and exercise. It has been stated that movements that do not require effort can also trigger attacks in migraine patients, but this is not seen in tension-type headache. Cervicogenic headache is also a less researched topic in general, and there is not enough data on kinesiophobia in this area. The aim of this study is to investigate the validity and reliability of the Tampa Kinesiophobia Scale for Headache in patients with migraine, tension-type and cervicogenic headaches for the Turkish population. The potential relationships between the scale and the beliefs about headache severity, disability, quality of life, anxiety and depression will also be evaluated and whether the characteristics of the three types of headaches are similar or different from kinesiophobia will be investigated.

Hypotheses: H0: The Tampa Kinesiophobia Scale for Headache is not valid and reliable for the Turkish population in patients with migraine, tension-type or cervicogenic headaches.

H1: The Tampa Kinesiophobia Scale for Headache is valid and reliable for the Turkish population in patients with migraine, tension-type or cervicogenic headaches.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with episodic/chronic migraine, tension-type headache and cervicogenic headache
* Being between the ages of 18-70,
* Being able to read, speak, understand and write Turkish in order to understand and correctly answer the items/questions of the surveys and scales.

Exclusion Criteria:

* Having a diagnosis of episodic/chronic migraine, tension-type headache, and any headache diagnosis other than cervicogenic headache,
* Having a history of any systemic disease such as malignant, inflammatory, acute fracture, surgery, neurological, psychological, or rheumatological.
* Not being able to read Turkish.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: In first enrollment, 1 minute
measure: Migraine Disability Assessment Questionnaire
timeFrame: In first enrollment, 1 minute
measure: Henry Ford Hospital Headache Disability Questionnaire
timeFrame: In first enrollment, 3 minutes
measure: Headache Impact Test-6
timeFrame: In first enrollment, 3 minutes
measure: Hospital Anxiety and Depression Scale
timeFrame: In first enrollment, 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Bozok University
state: Merkez
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
city: Mersin
country: Turkey
facility: Mersin University
state: Yenisehir
Study officials:
References:
citation: Schmidt S, Bullinger M. Current issues in cross-cultural quality of life instrument development. Arch Phys Med Rehabil. 2003 Apr;84(4 Suppl 2):S29-34. doi: 10.1053/apmr.2003.50244.
citation: Scirepreject. The Hospital Anxiety and Depression Scale (HADS) http://www.scireproject.com/book/export/html/78.
citation: Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
citation: Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeğinin Türkçe formunun geçerlik ve güvenilirlik çalışması. Türk Psikiyatri Dergisi 1997;8(4):280-287
citation: Dikmen PY, Bozdag M, Gunes M, Kosak S, Tasdelen B, Uluduz D, Ozge A. Reliability and Validity of Turkish Version of Headache Impact Test (HIT-6) in Patients with Migraine. Noro Psikiyatr Ars. 2020 Apr 24;58(4):300-307. doi: 10.29399/npa.24956. eCollection 2021.
citation: Kilinc HE, Oz M, Berberoglu U, Ozel Asliyuce Y, Onan D, Fanuscu A, Ulger O. Cross-cultural adaptation, reliability and validity of the Turkish version of the Henry Ford Hospital Headache Disability Inventory (HDI/T) in patients with cervicogenic headache. Disabil Rehabil. 2024 Feb;46(4):820-827. doi: 10.1080/09638288.2023.2178679. Epub 2023 Feb 14.
citation: 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.
citation: Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
citation: Martins IP, Gouveia RG, Parreira E. Kinesiophobia in migraine. J Pain. 2006 Jun;7(6):445-51. doi: 10.1016/j.jpain.2006.01.449.
citation: Amin FM, Aristeidou S, Baraldi C, Czapinska-Ciepiela EK, Ariadni DD, Di Lenola D, Fenech C, Kampouris K, Karagiorgis G, Braschinsky M, Linde M; European Headache Federation School of Advanced Studies (EHF-SAS). The association between migraine and physical exercise. J Headache Pain. 2018 Sep 10;19(1):83. doi: 10.1186/s10194-018-0902-y.
citation: İdiman F. Baş ağrılarında son kırk yıl. Ş. Bıçakcı, M. Öztürk, S. Üçler, N. Karlı ve A. Siva.(Editörler). Başağrısı Tanı ve Tedavi Güncel Yaklaşımlar, Türk Nöroloji Derneği Başağrısı Çalışma Grubu Uygulamaları. 2018:9-22
citation: Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
citation: Vlaeyen JWS, Kole-Snijders AMJ, Boeren RGB, van Eek H. Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain. 1995 Sep;62(3):363-372. doi: 10.1016/0304-3959(94)00279-N.
citation: Yilmaz, Ö. T., Yakut, Y., Uygur, F. ve Uluğ, N. (2011). Tampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği. Fizyoterapi Rehabilitasyon, 22(1), 44-49
citation: Burwinkle T, Robinson JP, Turk DC. Fear of movement: factor structure of the tampa scale of kinesiophobia in patients with fibromyalgia syndrome. J Pain. 2005 Jun;6(6):384-91. doi: 10.1016/j.jpain.2005.01.355.
citation: Kori SH, Miller RP, Todd D. Kinesophobia: a new view of chronic pain behaviour. Pain Management. 1990;3:35-43