Tampa Kinesiophobia Scale Modified for Headache (Kinesiophobia)

July 4, 2025 updated by: Dilara Onan, Bozok University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

329

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Elite Research and Surgical Hospital
  • Turkey
      • Ankara, Turkey
        • Gazi University
      • Ankara, Turkey
        • Ankara Atatürk Sanatoryum Training and Research Hospital
      • Edirne, Turkey
        • Trakya University
      • Gaziantep, Turkey
        • Gaziantep City Hospital
      • Istanbul, Turkey
        • Istanbul University
      • Istanbul, Turkey
        • Silivri State Hospital
      • Kütahya, Turkey
        • Kutahya Health Sciences University
      • Mersin, Turkey
        • Headache and Cognition Clinic of Aynur Ozge
      • Tokat, Turkey
        • Tokay Gaziosmanpaşa University
      • Zonguldak, Turkey
        • Zonguldak Bülent Ecevit University
    • Merkez
      • Yozgat, Merkez, Turkey, 66100
        • Bozok University
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey, 06560
        • Gazi University
    • Yenisehir
      • Mersin, Yenisehir, Turkey, 33100
        • Mersin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: In first enrollment, 1 minute
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.
In first enrollment, 1 minute
Headache Impact Test-6
Time Frame: In first enrollment, 3 minutes
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).
In first enrollment, 3 minutes
Hospital Anxiety and Depression Scale
Time Frame: In first enrollment, 3 minutes
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.
In first enrollment, 3 minutes
Migraine Disability Assessment Questionnaire
Time Frame: In first enrollment, 1 minute
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).
In first enrollment, 1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozok University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

May 28, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-GOKAEK2413_2024.11.20_190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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