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临床试验/NCT06271460
NCT06271460已完成不适用

Responsiveness and Minimal Important Change of the Turkish Versions of the Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Quebec Back Pain Disability Scale in Chronic Non-Specific Low Back Pain: A Prospective Clinimetric Study

Acibadem University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2024年4月1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
发起方
入组人数
80
试验地点
2
主要终点
Visual Analog Scale

研究概览

简要总结

This prospective observational clinimetric study aimed to compare the responsiveness of the Turkish versions of the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), and Quebec Back Pain Disability Scale (QBPDS) in adults with chronic non-specific low back pain. The study also aimed to estimate minimal important change (MIC) values for these instruments using a Global Perceived Effect (GPE) scale as an external anchor and to interpret the MIC estimates in relation to measurement error.

详细描述

Chronic non-specific low back pain is commonly associated with limitations in physical functioning and disability. Patient-reported outcome measures such as the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), and Quebec Back Pain Disability Scale (QBPDS) are widely used to assess disability in individuals with low back pain. However, the ability of these instruments to detect clinically meaningful change may differ across populations and cultural settings.

This prospective observational clinimetric study evaluated the responsiveness and clinical interpretability of the Turkish versions of the RMDQ, ODI, and QBPDS in adults with chronic non-specific low back pain. Participants were assessed at baseline and after completion of a standardized four-week physiotherapy program. Responsiveness was evaluated using distribution-based and anchor-based approaches, including effect size, standardized response mean, correlations between change scores and a Global Perceived Effect (GPE) scale, and receiver operating characteristic (ROC) curve analysis.

Minimal important change (MIC) values were estimated using the GPE scale as an external anchor and ROC analysis. Measurement error was also examined using the standard error of measurement (SEM) and minimal detectable change at the 95% confidence level (MDC95), allowing the MIC estimates to be interpreted in relation to measurement precision.

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

入选标准

  • Adults aged 18-65 years
  • Chronic non-specific low back pain of at least 12 weeks' duration
  • Low back pain not attributable to a specific spinal pathology
  • Ability to read and understand Turkish
  • Referral for physiotherapy
  • Provision of written informed consent

排除标准

  • Previous lumbar spine surgery
  • Specific spinal pathology or progressive neurological deficits
  • Systemic inflammatory or neurological disease
  • Myocardial infarction or cerebrovascular event within the previous 12 weeks
  • Cognitive impairment (Mini-Mental State Examination score <24)
  • Pregnancy
  • Recent intramuscular analgesic injection
  • Participation in structured exercise therapy during the previous 6 months

研究组 & 干预措施

Chronic Non-Specific Low Back Pain Cohort

Adults with chronic non-specific low back pain who were consecutively recruited from patients referred for physiotherapy. Participants were assessed at baseline and after completion of a four-week physiotherapy program to evaluate the responsiveness and minimal important change of the Turkish versions of the RMDQ, ODI, and QBPDS.

干预措施: Standardized Physiotherapy Program (Other)

结局指标

主要结局

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.

The Roland-Morris Disability Questionnaire

时间窗: baseline and through study completion, an average of 4 weeks

The Roland-Morris Disability Questionnaire (RMDQ) is a tool used to assess the disability of individuals with low back pain. In the current study, the RMDQ will be used to evaluate how participants' low back pain affects functional activities. The survey, which focuses on physical functions related to low back pain, consists of 24 questions. The questionnaire is most sensitive for patients with mild to moderate disability due to acute, subacute, or chronic low back pain. It is sensitive to change over time and has been shown to provide reliable measurements in determining the level of disability. The higher the score (0-24), the higher the level of pain-related disability.

The Quebec Back Pain Disability Scale

时间窗: baseline and through study completion, an average of 4 weeks

The Quebec Back Pain Disability Scale (QBPDS) is a condition-specific questionnaire designed to measure the level of functional disability of patients with low back pain. In the current study, QBPDS will be used to evaluate the disability of patients with low back pain during functional skills. The QBPDS consists of 20 items regarding daily activities selected from six relevant subdomains of functional skills for patients with low back pain. The scale is scored on a Likert scale from 0 to 5; 0 means "not difficult at all" and 5 means "I can't do it". The total score can range from 0 to 100; a higher score indicates a more severe disability. The minimum detectable change (90% confidence) for QBPDS is 15 points.

The Oswestry Disability Index

时间窗: baseline and through study completion, an average of 4 weeks

The Oswestry Disability Index (ODI) is a self-completed questionnaire used to assess the level of disability in patients with low back pain. In the current study, the ODI will be used to evaluate the impact of low back pain on patients' daily lives.The survey consists of ten sections focusing on different aspects of daily life, such as pain severity, personal care, weight lifting, walking, sitting, standing, sleep, sexual function, social life, and travel. Each section contains six statements scored from 0 to 5; The first expression is zero, indicating no disability. The scores of all questions are summed and then multiplied by two to obtain an index ranging from 0 to 100. The higher the score, the greater the disability.

The Perceived Global Impact

时间窗: through study completion, an average of 4 weeks

The Perceived Global Impact Scale is a tool used to assess the impact of various factors on an individual's health and well-being. In the current study, the amount of improvement in symptoms perceived by participants will be assessed at the end of treatment with the Perceived Global Impact Scale. Participants were asked, "How would you describe your current situation compared to the beginning of treatment?" The question was asked. questions 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.

Roland-Morris Disability Questionnaire (RMDQ)

时间窗: Baseline and 4 weeks

Functional disability related to low back pain was assessed using the Turkish version of the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ consists of 24 dichotomous items scored as 0 or 1, yielding a total score from 0 to 24. Higher scores indicate greater disability. Change scores were calculated as the 4-week follow-up score minus the baseline score, with negative change scores indicating improvement.

Quebec Back Pain Disability Scale (QBPDS)

时间窗: Baseline and 4 weeks

Functional disability related to low back pain was assessed using the Turkish version of the Quebec Back Pain Disability Scale (QBPDS). The QBPDS consists of 20 items assessing limitations in activities involving spinal movement and load transfer. Each item is rated from 0 to 5, yielding a total score from 0 to 100. Higher scores indicate greater functional disability. Change scores were calculated as the 4-week follow-up score minus the baseline score, with negative change scores indicating improvement.

Oswestry Disability Index (ODI)

时间窗: Baseline and 4 weeks

Functional disability related to low back pain was assessed using the Turkish version of the Oswestry Disability Index (ODI). The ODI consists of 10 sections assessing pain intensity and limitations in activities such as personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and sexual activity. Each section is scored from 0 to 5, and the total score is expressed as a percentage from 0% to 100%, with higher scores indicating greater disability. Change scores were calculated as the 4-week follow-up score minus the baseline score, with negative change scores indicating improvement.

次要结局

  • Visual Analog Scale (VAS) for Pain Intensity(Baseline and 4 weeks)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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