Responsiveness and Minimal Important Change of Turkish Pain-Related Psychological Measures in Chronic Non-Specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Fear-Avoidance Beliefs Questionnaire
研究概览
简要总结
This study evaluates the responsiveness and minimal important change of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and Pain Catastrophizing Scale in adults with chronic non-specific low back pain undergoing a 4-week rehabilitation program.
详细描述
Chronic non-specific low back pain is influenced by biological, psychological, and social factors, including fear-avoidance beliefs, kinesiophobia, and pain catastrophizing. The Fear-Avoidance Beliefs Questionnaire (FABQ), Tampa Scale for Kinesiophobia (TSK), and Pain Catastrophizing Scale (PCS) are commonly used to assess these pain-related psychological constructs.
This prospective, single-cohort measurement-property study evaluates the responsiveness of the Turkish versions of the FABQ, TSK, and PCS and examines their correspondence with patient-perceived global improvement. Participants undergo baseline assessment followed by a standardized 4-week rehabilitation program comprising 16 supervised physiotherapy sessions. Outcomes are reassessed after 4 weeks.
Responsiveness is evaluated using distribution-based indices and associations with the Global Rating of Change (GRC). Receiver operating characteristic analyses are used to examine discrimination between participants classified as improved and not improved and to estimate GRC-defined minimal important change values where appropriate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Adults aged 18-65 years
- •Chronic non-specific low back pain persisting for more than 12 weeks without a recognizable specific pathoanatomical cause
- •Ability to read and understand Turkish
- •Sufficient cognitive ability to complete self-reported questionnaires, defined as a Standardized Mini-Mental Test score ≥24
- •Provision of written informed consent
排除标准
- •Radiculopathy
- •Spinal infection, tumor, osteoporosis, vertebral fracture, recent trauma, or previous lumbar surgery
- •Recent spinal injection
- •Systemic disease affecting participation or interpretation
- •Cognitive impairment
- •Myocardial infarction or cerebrovascular event within the previous 12 weeks
- •Previous structured exercise therapy or pain neuroscience education for low back pain
- •Refusal of treatment
- •Inability to comply with the rehabilitation program
结局指标
主要结局
Fear-Avoidance Beliefs Questionnaire
时间窗: baseline and through study completion, an average of 4 weeks
Fear-Avoidance Beliefs Questionnaire is a tool used to assess fear-avoidance beliefs in patients with low back pain. In the current study, the fear and avoidance behaviors of the participants will be evaluated with FABQ. In the survey, which consists of sixteen questions and two subscales (physical activity and work), each question is scored on a six-point Likert scale (0: strongly disagree; 5: strongly agree). A high score in the evaluation is considered to indicate an increase in fear-avoidance behavior.
The Perceived Global Impact
时间窗: through study completion, an average of 4 weeks
The Global Perceived Impact Scale (GAES) is the usual gold standard for assessing minimal clinically significant change associated with pain in a patient's subjective perception of improvement (global perceived impact). In the current study, the amount of improvement in symptoms perceived by the participants will be evaluated at the end of treatment with GAES. Participants were asked "How would you describe your current condition compared to the beginning of treatment?" question will be asked. They will be asked to rate on a seven-point Likert scale (1: no change or things have gotten worse; 7: much better, a significant improvement). A score of 6 or above will be chosen as the threshold for clinically significant improvement.
Visual Analog Scale
时间窗: baseline and through study completion, an average of 4 weeks
Visual Analog Scale (VAS) is a pain rating scale used in clinical and research settings to measure the intensity or frequency of various symptoms. In the current study, VAS will be used to record participants' pain intensity. VAS consists of a single 10 cm line; The left end is described as "No pain" and the right end is described as "The most severe pain ever experienced". Patients will be asked to mark the severity of their current pain on a 10 cm line. When calculating, the marked point will be measured in cm. An increase in the score means that the intensity of the pain increases.
Tampa Scale for Kinesiophobia
时间窗: baseline and through study completion, an average of 4 weeks
The Tampa Scale for Kinesiophobia (TSK) will be used to assess participants' fear of movement. TSK is a 17-item scale developed to describe the fear of movement or re-injury. Each question is scored on a four-point Likert scale (1: strongly disagree; 4: strongly agree). The scoring of four items was reversed (items 4, 8, 12, and 16). Higher scores represent an increased fear of movement.
The Pain Catastrophizing Scale
时间窗: baseline and through study completion, an average of 4 weeks
The Pain Catastrophizing Scale will be used to assess participants' pain-related thoughts and feelings. It is self-administered and consists of 13 items and 3 subscales (helplessness, magnification, and rumination). It is scored using a five-point Likert-type scale (0: never; 4: always). High scores indicate high levels of catastrophizing.
Fear-Avoidance Beliefs Questionnaire (FABQ)
时间窗: Baseline and 4 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ) assesses fear-avoidance beliefs related to physical activity and work. The questionnaire consists of 16 items. The Physical Activity subscale includes items 2-5 and ranges from 0 to 24, while the Work subscale includes items 6, 7, 9-12, and 15 and ranges from 0 to 42. Higher scores indicate greater fear-avoidance beliefs.
Tampa Scale for Kinesiophobia (TSK)
时间窗: Baseline and 4 weeks
Tampa Scale for Kinesiophobia (TSK) assesses fear of movement or reinjury. The scale consists of 17 items scored on a 4-point Likert scale. After reverse scoring of the relevant items, total scores range from 17 to 68, with higher scores indicating greater kinesiophobia.
Pain Catastrophizing Scale (PCS)
时间窗: Baseline and 4 weeks
Pain Catastrophizing Scale (PCS) assesses catastrophic thinking related to pain. The scale consists of 13 items scored on a 0-4 Likert scale and provides Rumination, Magnification, Helplessness, and Total scores. Higher scores indicate greater pain catastrophizing.
次要结局
- Pain Intensity - Visual Analog Scale (VAS)(Baseline and 4 weeks)
