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MigraineKinesiophobiaNCT06857357

Tampa Kinesiophobia Scale Modified for Headache

An observational study of Migraine, run by Bozok University at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Migraine
What is being tested?
Questionnaires
How many people
329 participants
Where
14 sitesin 2 countries
Study dates
2 Jan 2025to 30 May 2025
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients between the ages of 18-70 who applied to neurology departments of Mersin University, Gazi University, Zonguldak Bülent Ecevit University, Kütahya Health Sciences University, Gaziantep City Hospital, Silivri State Hospital, Trakya University, and Elite Research and Surgery Hospital and who were diagnosed with episodic/chronic migraine 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.

Who may be able to join

  • Being diagnosed with episodic/chronic migraine,
  • 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.

Who cannot join

  • Having a diagnosis of episodic/chronic migraine,
  • Having a history of any systemic disease such as malignant, inflammatory, acute fracture, surgery, neurological, psychological, or rheumatological.
  • Not being able to read Turkish.

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Turkey (Türkiye)13 sites

  • Gazi University

    Ankara, Yenimahalle, 06560

  • Ankara Atatürk Sanatoryum Training and Research Hospital

    Ankara

  • Gazi University

    Ankara

  • Trakya University

    Edirne

  • Gaziantep City Hospital

    Gaziantep

  • İstanbul University

    Istanbul

  • Silivri State Hospital

    Istanbul

  • Kütahya Health Sciences University

    Kütahya

  • Mersin University

    Mersin, Yenisehir, 33100

  • Headache and Cognition Clinic of Aynur Ozge

    Mersin

  • Tokay Gaziosmanpaşa University

    Tokat Province

  • Bozok University

    Yozgat, Merkez, 66100

  • Zonguldak Bülent Ecevit University

    Zonguldak

Other trials in Turkey (Türkiye)

Cyprus1 site

  • Elite Research and Surgical Hospital

    Nicosia

Other trials in Cyprus

About this study

Official title: Evaluation of Kinesiophobia in Patients With Headache Using the Tampa Kinesiophobia Scale Modified for Headache: Turkish Version, Validity and Reliability Study

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. The aim of this study is to investigate the validity and reliability of the Tampa Kinesiophobia Scale for Headache in patients with migraine for the Turkish population. The potential relationships between the scale and the beliefs about headache intensity, disability, headache impact, 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.

Hypothesis:

H0: The Tampa Kinesiophobia Scale for Headache is not valid and reliable for the Turkish population in patients with migraine H1: The Tampa Kinesiophobia Scale for Headache is valid and reliable for the Turkish population in patients with migraine

Conditions
Migraine
Being tested
Questionnaires
Keywords
Migraine, kinesiophobia
Medical subject headings
Migraine Disorders, Kinesiophobia

What participants receive

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

  • QuestionnairesOther

    The Tampa Kinesiophobia Questionnaire is a 17-question questionnaire that assesses avoidance of injury and fear of movement. The scale is scored using a Likert scale (1 = Strongly disagree, 4 = Strongly agree). Items 4, 8, 12 and 16 are reversed to calculate the total score of the scale. The total score is between 17 and 68. As the score of the person increases, it is understood that their kinesiophobia is high. A total score higher than 37 is considered as high kinesiophobia. However, since not every item of the questionnaire addresses patients with headache in this study, some questions were removed, some questions were edited and some questions were added to create a kinesiophobia questionnaire for headache. The newly created questionnaire consists of 23 items. Again, it is scored using a Likert scale with "1 = Strongly disagree, 4 = Strongly agree". As the score increases, it is understood that the level of kinesiophobia is high.

What is being measured

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

  1. Visual Analog Scale

    The visual analog scale consists of the pain level that the person currently experiences with a vertical line on a plane. The pain felt by the person is marked as "0: no pain at all", "10: I feel very severe pain". Scoring is based on the vertical marking the participant makes for the pain he/she marks on the plane with a ruler.

    Measured: In first enrollment, 1 minute

  2. Migraine Disability Assessment Questionnaire

    Disability of migraine patients will be assessed with the Migraine Disability Assessment Questionnaire (MEDA). MEDA assesses the last 3 months of disability and consists of a 5-item self-administered test covering disability-related activities at work/school, housework, family, and social or leisure. The total number of days missed in these activities is the total score and classifies disability as minimal disability (0-5 points), mild disability (6-10 points), moderate disability (11-20 points), or severe disability (≥21).

    Measured: In first enrollment, 1 minute

  3. Headache Impact Test-6

    The impact of headache will be assessed with the Headache Impact Test-6 (HIT-6). HIT-6 is a quality of life 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 the six items and ranges from 36 to 78 points. (≤49 = little/no impact, 50-55 = some impact, 56-59 = significant impact, and 60-78 = severe impact; higher scores indicate greater deterioration in quality of life).

    Measured: In first enrollment, 3 minutes

  4. Hospital Anxiety and Depression Scale

    Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS). 7 items of the 14-item scale assess anxiety and 7 items assess depression symptoms. It is scored between 0-3 points. By summing the subscale scores, 0-21 points can be obtained from each of the Depression and Anxiety subscales. It is stated that 0-7 points are the normal range for each subscale, 8-10 points suggest the presence of a mood disorder, and 11 and above points indicate a possible mood disorder. In addition, there are recommended cut-off scores for mild (8-10 points), moderate (11-15) and severe (16 and above) cases.

    Measured: In first enrollment, 3 minutes

Timeline

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

  1. First posted4 Mar 2025
  2. Study start2 Jan 2025
  3. Primary completion28 May 2025
  4. Study completion30 May 2025

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
329 participants (actual)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06857357
Sponsor's protocol ID
2024-GOKAEK2413_2024.11.20_190
Acronym
Kinesiophobia
Status last verified
Jul 2025
First submitted
26 Feb 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12692769

  • Scirepreject. The Hospital Anxiety and Depression Scale (HADS) http://www.scireproject.com/book/export/html/78.

  • Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

    PubMed 12914662

  • 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

  • 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.

    PubMed 34924791

  • 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.

    PubMed 36788454

  • 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

  • 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.

    PubMed 6226917

  • 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.

    PubMed 16750801

  • 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.

    PubMed 30203180

  • 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

  • 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.

    PubMed 29368949

  • 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.

    PubMed 8657437

  • 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

  • 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.

    PubMed 15943960

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by Bozok University at 14 sites in 2 countries.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Turkey (Türkiye), Cyprus. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: In first enrollment, 1 minute). The study lists 4 primary outcomes in all. 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 NCT06857357, which also lists 16 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 8 Jul 2025.

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