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临床试验/CTRI/2025/09/094498
CTRI/2025/09/094498尚未招募不适用

Development and validation of lumbar risk prediction model and its reliability testing for chronic non specific low back pain

Nityal Kumar Alagingi1 个研究点 分布在 1 个国家目标入组 623 人开始时间: 2025年9月22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
623
试验地点
1
主要终点
Development of a lumbar risk prediction model for chronic non-specific low back pain

研究概览

简要总结

**Public Title:**Development and Validation of Lumbar Risk Prediction Model for Chronic Non-Specific Low Back Pain

**Brief Summary for CTRI Registration:**This prospective cohort study aims to develop, validate, and assess the reliability of the Lumbar Risk prediction model, which estimates the risk of chronic non-specific low back pain (CNSLBP) among young adults aged 19–45 years. NSLBP is a multifactorial condition with no specific pathology, and early identification of high-risk individuals can significantly reduce chronicity and associated disability.

The study involves three phases:

  1. Phase 1 – Risk Factor Identification: A comprehensive literature review and expert survey will identify key risk factors using the biopsychosocial model.
  2. Phase 2 – Model Development & Validation: A prediction model will be developed using regression techniques and internally validated with 495 participants categorized into three groups—no pain, acute LBP, and chronic LBP. The model’s performance will be evaluated using AUC, sensitivity, specificity, and calibration plots.
  3. Phase 3 – Reliability Testing: Inter-rater and test-retest reliability will be assessed in a clinical setting using Intraclass Correlation Coefficient (ICC) on a sample of 60 participants.

Primary Objectives:

  • To develop and validate a predictive model to identify individuals at high risk of developing chronic NSLBP.
  • To assess the reliability (inter-rater and test-retest) of the developed model in a clinical setting.

**Outcome:**A validated, reliable, and clinically applicable Lumbar Risk model that can aid physiotherapists and clinicians in predicting and managing the risk of chronic NSLBP effectively.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Age between 19 to 45 Non specific low back pain.

排除标准

  • Any surgery Specific low back pain.

结局指标

主要结局

Development of a lumbar risk prediction model for chronic non-specific low back pain

时间窗: Development of a lumbar risk prediction model for chronic non-specific low back pain

次要结局

  • Model validity (predictive accuracy)(Reliability of predictor variables and scoring system)

研究者

发起方
Nityal Kumar Alagingi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nityal Kumar ALagingi

Assistant Professor

研究点 (1)

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