Culturally Adapted Pain Science Education (PSE) for Chronic Low Back Pain in India: A feasibility Randomized Controlled Trial

Background : Chronic Low back pain (CLBP) is highly prevalent and results in socioeconomic burden to an individual and to the government as there is an increased health care cost. As the pathology of CLBP is confined with hyper sensitivity of central nervous system leads to produce amplified pain response for a relatively suboptimal stimulus. The characteristic attitude of overprotection by an individual with low back pain (LBP) too contribute towards the mechanism of central hypersensitivity. Pain Science Education (PSE) along with graded exposure of physical activity and exercise are consider to be an effective intervention for CLBP. However, the content of PSE needs to be translated and culturally validated to suit to the local population. In India, for the first time such work has been completed, but feasibility to conduct a Randomized Controlled trial using the newly developed PSE education has not been completed. This study has been planned to fill the gap in research. Methodology : It’s an assessor-blinded feasibility randomized controlled trial (RCT),which included patients with CLBP with the duration of more than three months from the age group above 18 years and patients with additional comorbidity such as Severe psychiatric conditions (e.g., severe depression, schizophrenia)acute medical conditions preventing physical activity, neurological deficits or cognitive impairments, recent surgery or trauma affecting the back (within six months),Pregnancy or postpartum within six months. Patients were randomly allotted to the either control group or experimental group., Control group received guideline based physiotherapy which includes assurance, patient education, back and core muscle exercise, walking for 30 minutes, the experimental group received Culturally validated Pain Science Education(PSE) for an hour and advised to recollect the points and to undergo thirty minutes of walking every day for about 30 minutes, the feasibility criteria which includes Recruitment rate,acceptability,adherence to intervention etc. Two secondary outcome measures were also applied namely, Numerical Pain Rating Scale and Rolland Morris Disability Index on day one and day seven. Results : This study has met the preset Recruitment rate of 80%, Acceptability by patients of about 75% and the adherence rate of 90%, also there was a preliminary effect of culturally developed PSE was found. Conclusion : In India, feasibility of pain science education (PSE) as an intervention for CLBP has been established and a preliminary result are in favor of PSE group, hence it may be considered as a main stream treatment utilizing the available resource developed. A definite trial to prove the efficacy of PSE in CLBP is warranted. Trial registration: Clinical Trials Registry India (CTRI), CTRI/2022/07/044069; prospectively registered on 15 July 2022.