NCT07673159

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

validityreliabilitykinesiophobiachronic pain

Outcome Measures

Primary Outcomes (1)

  • Turkish version 9-item Tampa Scale of Kinesiophobia

    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

Secondary Outcomes (4)

  • Fear-Avoidance Beliefs Questionnaire

    Baseline

  • Pain Catastrophizing Scale

    Baseline

  • Fear-Avoidance Components Scale

    Baseline

  • Numeric Pain Rating Scale

    Baseline

Study Arms (1)

Patient with chronic spinal pain

Other: Questionnaire-based assessment

Interventions

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.

Patient with chronic spinal pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adults aged 18 to 65 years with chronic spinal pain, including chronic neck or low back pain lasting longer than 3 months. Participants will be recruited online through social media announcements and will complete the study questionnaires using Google Forms. Eligible participants will be individuals who report a pain intensity score of 3 or higher on the Numeric Pain Rating Scale and who are able to read and understand Turkish.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 36128900BACKGROUND
  • 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.

    PMID: 39871687BACKGROUND
  • 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.

    PMID: 26201395BACKGROUND

MeSH Terms

Conditions

KinesiophobiaChronic Pain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the department

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

May 17, 2025

Primary Completion

May 30, 2026

Study Completion

June 5, 2026

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study data will be collected from human participants and may include potentially identifiable demographic and clinical information. Data will be used only by the research team for the purposes of this methodological validation study. Aggregate results will be reported in scientific publications without identifying any participant.

Locations