- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Konyaaltı
-
Antalya, Konyaaltı, Turchia (Türkiye), 07070
- Akdeniz University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Turkish version 9-item Tampa Scale of Kinesiophobia
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fear-Avoidance Beliefs Questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TBAEK-613/03.07.2025
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dolore spinale cronico
-
Third Affiliated Hospital, Sun Yat-Sen UniversityAttivo, non reclutanteInsufficienza epatica acuta su Chronic (ACLF)Cina
-
Cairo UniversityCompletatoSCOPO PAIN (VAS) a 24 ore dopo l'interventoEgitto
-
University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team
-
Yaqrit LtdKing's College Hospital NHS Trust; University College, London; Royal Free Hospital... e altri collaboratoriNon ancora reclutamentoCirrosi epatica | Insufficienza epatica acuta su Chronic (ACLF)
-
Institute of Liver and Biliary Sciences, IndiaNon ancora reclutamentoInsufficienza epatica acuta su Chronic (ACLF)
-
Institute of Liver and Biliary Sciences, IndiaNon ancora reclutamentoInsufficienza epatica acuta su Chronic (ACLF)
-
Qilu Hospital of Shandong UniversityAttivo, non reclutanteInsufficienza epatica acuta su Chronic correlata all'HBVCina
-
Qilu Hospital of Shandong UniversityReclutamentoPaesaggio a cellule singolo di pazienti con insufficienza epatica acuta su cronica correlata all'HBVInsufficienza epatica acuta su Chronic correlata all'HBVCina
-
Qilu Hospital of Shandong UniversityReclutamentoCirrosi epatica HBV correlata | HBV (virus dell'epatite B) | Insufficienza epatica acuta su Chronic correlata all'HBVCina
-
King Abdulaziz UniversityReclutamentoDisturbi temporomandibolari (TMD) | Dolore dell'ATM | Arteterapia | TMJ - orale & amp; chirurgia maxillofaciale | Wilkes 1 e 2 | TMD Art Pain StudyArabia Saudita
Prove cliniche su Questionnaire-based assessment
-
The University of Texas Medical Branch, GalvestonIscrizione su invitoFerita da arma da fuocoStati Uniti
-
Baskent UniversityNon ancora reclutamentoDepressione - Disturbo depressivo maggioreTurchia (Türkiye)
-
Tanta UniversityCompletatoConsapevolezza | Medici | Anomalie ECG | Dolore al torace ischemico acutoEgitto
-
New York State Psychiatric InstituteUniversity of Miami; Columbia University; University of Southern California; Feinstein...SospesoPartecipanti saniStati Uniti
-
Idoven 1903 S.L.Karolinska Institutet; AstraZeneca; Region Stockholm; Instituto de Investigación... e altri collaboratoriReclutamentoArresto cardiaco | Fattori di rischio cardiovascolareSpagna, Svezia
-
National Yang Ming UniversityRitirato
-
Oregon Health and Science UniversityJohn & Tami Marick FoundationNon ancora reclutamentoDepressione perinatale
-
Healthy.io Ltd.CompletatoMalattie acute e croniche rilevabili nelle urineStati Uniti
-
Guy's and St Thomas' NHS Foundation TrustPhilips HealthcareCompletato
-
University of PlymouthNon ancora reclutamentoMorbo di Parkinson | ParkinsonRegno Unito