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临床试验/CTRI/2025/09/094664
CTRI/2025/09/094664尚未招募不适用

Development, Validation and Reliability Testing of Sleep Disability Questionnaire in Individuals with Chronic Low Back Pain

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2025年10月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
51
试验地点
1
主要终点
Sleep Disability Questionnaire

研究概览

简要总结

Background Chronic low back pain (CLBP) is one of the most common musculoskeletal illnesses, affecting up to 80% of people at some point in their lives and making them unable to work. About 70% of people with CLBP say they have trouble sleeping, which is a big deal. Chronic pain and sleep problems are linked in complicated ways, but the instruments we use to assess them don’t always take into consideration the unique problems that people with CLBP encounter.

MethodsThe investigation will happen in two separate stages:

Phase 1 In this first step, we will create and test the Sleep Disability Questionnaire (SDQ). This method will include finding the right domains and things by talking to experts, interviewing patients, and doing extensive evaluations of the literature. We will use the Delphi approach to make sure the material is valid, and then we will do pilot testing to see how useful and effective the questionnaire is. We will use exploratory factor analysis to look at construct validity.

Phase  2 The second step will be all about checking the SDQ’s reliability and other psychometric qualities, such as internal consistency and reliability between and within raters. We will choose 51 CLBP patients who have serious sleep problems based on criteria we have already set.

ResultsThe study will use kappa statistics and indices like the Item-Level Content Validity Index (I-CVI) and the Scale-Level Content Validity Index (S-CVI) to check the content validity. We will also use normalcy tests like the Kolmogorov-Smirnov and Shapiro-Wilk tests. We will use regression analysis, Cronbach’s alpha, Pearson or Spearman correlations, Bland-Altman plots, and the intraclass correlation coefficient (ICC) to check for reliability.

C****onclusionthe goal of our project is to make a new, dependable Sleep Disability Questionnaire that is specifically designed for people with CLBP and test it fully. We think that the SDQ will give researchers and doctors a better way to look at and treat sleep problems in this group of people. This will lead to better patient outcomes and a better quality of life over time.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Individuals with chronic mechanical low back pain.
  • BMI as per Asian classification
  • Individuals reported to have fair to severe sleep disturbances on numeric sleep disturbance scale after developing back pain.
  • Both Male and female.
  • Age between 20-50 years
  • Pain more than 5 on VAS.

排除标准

  • Acute low back pain (less than 3 months)
  • History of spinal surgery in last 6 month.
  • History of taking treatment for insomnia in last 6 months.
  • suffering from other comorbid illness.
  • Suffering from metabolic disorders.
  • History of sleep apnea related problem.
  • History of Restless leg syndrome.

结局指标

主要结局

Sleep Disability Questionnaire

时间窗: baseline and after 48 hours

次要结局

未报告次要终点

研究者

发起方
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mousumi Saha

MMIPR

研究点 (1)

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