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临床试验/CTRI/2025/12/099429
CTRI/2025/12/099429尚未招募不适用

Development, Validation, Reliability And Psychometric Testing Of Comprehensive Functional And Psychological Assessment Scale In Patients 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12月31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
Comprehensive Functional and Psychological Assessment

研究概览

简要总结

Background: Low Back Pain (LBP) ranks as one of the most prevalent musculoskeletal conditions around the world. The average lifetime prevalence of LBP in Northern-India was reported to be 57%, with women (65%) having a significantly greater prevalence than men (47%). There is limited literature available on assessing the combined impact on functional disability and psychological status in patients with chronic LBP patients in Northern India. The aim of the study is to validate and test all the psychometric properties of Comprehensive Assessment scale for patients with chronic LBP in northern India.

Study Design: A cross-sectional study

Methods: The study will be conducted in 3 phases: 1) development phase, 2) validation phase, 3) testing psychometric properties. For the formation of domains and framing a pre-final draft for the scale development, 7-8 patients having chronic LBP from the past year will be interviewed, followed by related literature searches and expert panel opinions.  The draft will be validated in terms of content validity via the Delphi survey method, construct validity via confirmatory factor analysis, and concurrent validity will be analysed by correlating the comprehensive assessment scale with other valid questionnaire. The data will be collected from patients to test the final draft of the comprehensive assessment scale for its psychometric properties.

Statistical analysis will be done using IBM SPSS software (version 26). The data collected from the patients will be analysed for its absolute and relative reliability and other psychometric properties like sensitivity, specificity, Small-Worthwhile Change, Minimal Detectable Change, Standard Error Mean and Coefficient of Variation.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Individuals with chronic mechanical low back pain.
  • Duration of low back pain: minimum of 6 months.
  • Age between 20-60 years.
  • Both male and female.
  • BMI as per Asian Classification
  • Pain more than 5 on NPRS.

排除标准

  • Patients having low back pain less than 6 months duration.
  • History of spinal surgery in last 1 year
  • Patients with definite neurodeficit will be excluded.
  • Pregnant females.
  • Spinal injection, fracture, malignancy, spondylolisthesis, PIVD.
  • Not willing to participate.
  • Inflammatory Arthritis.
  • patients with psychosomatic illness.

结局指标

主要结局

Comprehensive Functional and Psychological Assessment

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

Aditi Popli

Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

研究点 (1)

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