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临床试验/NCT07673159
NCT07673159已完成不适用

Turkish Validity and Reliability Study of the 9-Item Tampa Scale of Kinesiophobia in Individuals With Chronic Spinal Pain

Akdeniz University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Turkish version 9-item Tampa Scale of Kinesiophobia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Patient with chronic spinal pain

干预措施: Questionnaire-based assessment (Other)

结局指标

主要结局

Turkish version 9-item Tampa Scale of Kinesiophobia

时间窗: 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.

次要结局

  • Fear-Avoidance Beliefs Questionnaire(Baseline)
  • Pain Catastrophizing Scale(Baseline)
  • Fear-Avoidance Components Scale(Baseline)
  • Numeric Pain Rating Scale(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Gül

Head of the department

Akdeniz University

研究点 (1)

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