- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Konyaaltı
-
Antalya, Konyaaltı, 터키 (Türkiye), 07070
- Akdeniz University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Turkish version 9-item Tampa Scale of Kinesiophobia
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fear-Avoidance Beliefs Questionnaire
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TBAEK-613/03.07.2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
만성 척추 통증에 대한 임상 시험
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
Blayne WelkLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St....모병Spina Bifida 또는 Spinal Dysraphism캐나다
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Rennes University Hospital완전한
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
Questionnaire-based assessment에 대한 임상 시험
-
University Hospital, Toulouse완전한
-
Qazvin University Of Medical Sciences완전한
-
Qazvin University Of Medical Sciences알려지지 않은
-
Vanderbilt University Medical Center모집하지 않고 적극적으로
-
New Jersey Institute of TechnologyChildren's Hospital of Philadelphia; National Eye Institute (NEI); Rutgers University; Salus...완전한