- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07673159
Turkish Validation of the 9-Item Tampa Scale of Kinesiophobia
Turkish Validity and Reliability Study of the 9-Item Tampa Scale of Kinesiophobia in Individuals With Chronic Spinal Pain
This observational methodological study aims to evaluate the validity and reliability of the Turkish version of the 9-item Tampa Scale of Kinesiophobia (TSK-9) in individuals with chronic spinal pain. Chronic spinal pain is commonly associated with fear of movement, avoidance behavior, pain catastrophizing, and disability. Therefore, a short and practical Turkish measurement tool may be useful for both clinical assessment and research.
Participants with chronic neck or low back pain will complete self-report questionnaires, including the Turkish TSK-9, the Fear-Avoidance Beliefs Questionnaire, the Pain Catastrophizing Scale, the Fear-Avoidance Components Scale, and the Numeric Pain Rating Scale. The Turkish TSK-9 will be administered again 7 days after the first assessment in a subgroup of participants to evaluate test-retest reliability.
No intervention, invasive procedure, clinical test, or laboratory test will be performed. Data will be collected online using Google Forms.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study is an observational methodological validation study designed to investigate the psychometric properties of the Turkish version of the 9-item Tampa Scale of Kinesiophobia (TSK-9) in individuals with chronic spinal pain.
The original Tampa Scale of Kinesiophobia is a widely used measure for evaluating fear of movement and reinjury in people with pain. However, shorter versions of the scale have been proposed in the literature, and the 9-item version includes two domains: activity avoidance and somatic focus. The purpose of this study is to translate, culturally adapt, and evaluate the validity and reliability of the Turkish TSK-9 in individuals with chronic neck or low back pain.
The study will be conducted online. Participants will be recruited through social media announcements and will complete the study questionnaires using Google Forms. Eligible participants will be adults aged 18 to 50 years who report chronic spinal pain lasting longer than 3 months and a self-reported pain intensity of at least 3 points on the Numeric Pain Rating Scale.
The first assessment will include sociodemographic and clinical questions, the Turkish TSK-9, the Fear-Avoidance Beliefs Questionnaire, the Pain Catastrophizing Scale, the Fear-Avoidance Components Scale, and the Numeric Pain Rating Scale. Pain intensity will be assessed both at rest and during activity. To evaluate test-retest reliability, the Turkish TSK-9 will be administered again 7 days after the first assessment in participants who agree to complete the second evaluation.
The study will include at least 90 participants. This sample size was determined according to the commonly used participant-to-item ratio of 10 participants per item for questionnaire validation studies. Since the TSK-9 includes 9 items, a minimum of 90 participants is planned.
Reliability will be examined using internal consistency and test-retest reliability analyses. Internal consistency will be assessed using Cronbach's alpha. Test-retest reliability will be evaluated using the intraclass correlation coefficient, 95% confidence interval, standard error of measurement, and minimal detectable change. Construct validity will be examined by analyzing the correlations between the Turkish TSK-9 and measures of fear-avoidance beliefs, pain catastrophizing, fear-avoidance components, and pain intensity.
No treatment, intervention, invasive procedure, clinical test, or laboratory test will be applied in this study. Participation is voluntary, and the study is not expected to involve any physical risk or harm to participants.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
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Konyaaltı
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Antalya, Konyaaltı, Turecko (Türkiye), 07070
- Akdeniz University
-
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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
- Having chronic spinal pain lasting longer than 3 months
- Having neck or low back pain
- Having a self-reported pain intensity score of 3 or higher on the Numeric Pain Rating Scale
- Volunteering to participate in the study
- Being able to read and understand Turkish
Exclusion Criteria:
- History of spinal surgery
- History of vertebral fracture
- Diagnosis of radiculopathy and/or disc herniation with neurological involvement
- Use of analgesic medication within the last 7 days
- History of cancer
- Self-reported serious neurological disease
- Self-reported serious psychiatric disease
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Patient with chronic spinal pain
|
Participants will complete self-report questionnaires, including the Turkish 9-item Tampa Scale of Kinesiophobia, Fear-Avoidance Beliefs Questionnaire, Pain Catastrophizing Scale, Fear-Avoidance Components Scale, and Numeric Pain Rating Scale.
The Turkish 9-item Tampa Scale of Kinesiophobia will be administered again 7 days after the first assessment in a subgroup of participants to evaluate test-retest reliability.
No treatment, invasive procedure, clinical test, or laboratory test will be performed.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Turkish version 9-item Tampa Scale of Kinesiophobia
Časové okno: Baseline and 7 days
|
The Turkish 9-item Tampa Scale of Kinesiophobia (TSK-9) is a self-report questionnaire used to assess fear of movement and reinjury in individuals with pain.
The scale consists of 9 items and two domains: activity avoidance and somatic focus.
Each item is scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree).
The activity avoidance domain includes 5 items and ranges from 5 to 20 points.
The somatic focus domain includes 4 items and ranges from 4 to 16 points.
Higher scores indicate greater kinesiophobia.
|
Baseline and 7 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Fear-Avoidance Beliefs Questionnaire
Časové okno: Baseline
|
The Fear-Avoidance Beliefs Questionnaire is a self-report questionnaire used to assess fear-avoidance beliefs related to physical activity and work.
It includes 16 items and two subscales: a physical activity subscale and a work subscale.
Each item is scored on a 7-point Likert scale ranging from 0 (completely disagree) to 6 (completely agree).
Higher scores indicate greater fear-avoidance beliefs.
|
Baseline
|
|
Pain Catastrophizing Scale
Časové okno: Baseline
|
The Pain Catastrophizing Scale is a self-report questionnaire used to assess catastrophic thoughts and feelings related to pain.
It consists of 13 items and includes three subscales.
Each item is scored on a 5-point scale.
The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
|
Baseline
|
|
Fear-Avoidance Components Scale
Časové okno: Baseline
|
The Fear-Avoidance Components Scale is a self-report questionnaire used to assess cognitive, behavioral, and emotional components of fear avoidance in individuals with painful medical conditions.
It consists of 20 items scored from 0 (completely disagree) to 5 (completely agree).
The total score ranges from 0 to 100.
Higher scores indicate greater fear avoidance.
|
Baseline
|
|
Numeric Pain Rating Scale
Časové okno: Baseline
|
The Numeric Pain Rating Scale is used to assess self-reported pain intensity.
Participants rate their pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Pain intensity will be assessed at rest and during activity.
Higher scores indicate greater pain intensity.
|
Baseline
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Pontes-Silva A, Dibai-Filho AV, Costa de Jesus SF, Santos de Oliveira LA, Bassi-Dibai D, Fidelis de Paula Gomes CA, Avila MA. The best structure of the Tampa Scale for Kinesiophobia for patients with chronic low back pain has two domains and nine items. Clin Rehabil. 2023 Mar;37(3):407-414. doi: 10.1177/02692155221128829. Epub 2022 Sep 21.
- Morais DN, Pontes-Silva A, Barreto FS, Pinheiro JS, Oliveira LAS, Bassi-Dibai D, Fidelis-de-Paula-Gomes CA, Avila MA, Dibai-Filho AV. The 9-item Tampa Scale for Kinesiophobia (TSK-9) has adequate measurement properties in patients with chronic low back pain. Clin Rehabil. 2025 Apr;39(4):486-492. doi: 10.1177/02692155251315060. Epub 2025 Jan 28.
- Kikuchi N, Matsudaira K, Sawada T, Oka H. Psychometric properties of the Japanese version of the Tampa Scale for Kinesiophobia (TSK-J) in patients with whiplash neck injury pain and/or low back pain. J Orthop Sci. 2015 Nov;20(6):985-92. doi: 10.1007/s00776-015-0751-3. Epub 2015 Jul 23.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
- TBAEK-613/03.07.2025
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