Psychometric Testing and Validation of Comprehensive Assessment Scale for Chronic Low Back Pain in Northern Indian Population: A Research Protocol

Introduction: Low Back Pain (LBP) ranks as one of the most prevalent musculoskeletal conditions worldwide. The average lifetime prevalence of LBP in Northern India is reported to be 57%, with women (65%) exhibiting a significantly higher prevalence than men (47%). Need of the study: The existing literature evaluating the combined effects of functional disability and psychological status in patients with chronic LBP in Northern India is quite limited. In countries like India, clinicians and researchers often rely on assessment scales developed in Western nations. However, no indigenous scales exist that simultaneously measure both functional limitations and psychological aspects in chronic LBP patients. When these internationally developed scales are used in Northern Indian clinical settings, they may fail to accurately capture patient progress during assessments and reassessments, as they are designed with different cultural and geographical considerations in mind. Aim: The study aims to validate and test the psychometric properties of a Comprehensive Assessment Scale for patients with chronic LBP in Northern India. Materials and Methods: The present cross-sectional study will be conducted at MM Super-Specialty Hospital, Mullana, Ambala, Haryana, India. The duration of the study will be from February 2025 to February 2026, and it will comprise three phases: 1) development phase, 2) validation phase, and 3) testing of psychometric properties. For the formation of domains and the framing of a pre-final draft for scale development, 7-8 patients with chronic LBP who have been experiencing symptoms for the past year will be interviewed over three rounds. This will be followed by literature searches and opinions from an expert panel. The draft will be validated in terms of content validity via the Delphi survey method. Construct validity will be examined through confirmatory factor analysis, and concurrent validity will be analysed by correlating the Comprehensive Assessment Scale (CAS) with other validated questionnaires such as the Oswestry Disability Index (ODI) and the Roland-Morris Disability Questionnaire (RMDQ-24). Data will be collected from patients to test the final draft of the CAS for its psychometric properties. Statistical analysis will be performed using IBM Statistical Package for the Social Sciences (SPSS) software (version 26). The data collected will be analysed for absolute and relative reliability, as well as other psychometric properties such as sensitivity, specificity, small worthwhile change, minimal detectable change, standard error of mean, and coefficient of variation.