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Chronic Spinal PainNCT07673159

Turkish Validation of the 9-Item Tampa Scale of Kinesiophobia

An observational study of Chronic Spinal Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Spinal Pain
What is being tested?
Questionnaire-based assessment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 May 2025to 5 Jun 2026
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Akdeniz University

    Antalya, Konyaaltı, 07070

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Questionnaire-based assessment
Keywords
validity, reliability, kinesiophobia, chronic pain
Medical subject headings
Kinesiophobia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire-based assessmentOther

    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.

Study groups in NCT07673159
Study groupRoleWhat they receive
Patient with chronic spinal painNot described
Receives: Other: Questionnaire-based assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 7 days

Secondary outcomes (4)
  1. Fear-Avoidance Beliefs Questionnaire

    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.

    Measured: Baseline

  2. Pain Catastrophizing Scale

    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.

    Measured: Baseline

  3. Fear-Avoidance Components Scale

    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.

    Measured: Baseline

  4. Numeric Pain Rating Scale

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study start17 May 2025
  3. Primary completion30 May 2026
  4. Study completion5 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
90 participants (actual)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07673159
Sponsor's protocol ID
TBAEK-613/03.07.2025
Status last verified
Jun 2026
First submitted
23 Jun 2026
Last updated
29 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 36128900
  • 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.

    PubMed 39871687
  • 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.

    PubMed 26201395

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Spinal Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Turkish version 9-item Tampa Scale of Kinesiophobia (time frame: Baseline and 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07673159, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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