Tampa Kinesiophobia Scale Modified for Headache

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

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Key information

Conditions

Migraine Anxiety Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Kinesiophobia Mental Disorders Migraine Disorders Nervous System Diseases Phobic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elite Research and Surgical Hospital, Nicosia, Cyprus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaires

Other

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.

Primary outcomes

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.
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).
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).
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.

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

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

Acronym: Kinesiophobia

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 4, 2025
Registry last updated: Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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