Effectiveness of pain education on pain, disability, quality of life and self-efficacy in chronic low back pain: A randomized controlled trial

Background Low back pain is one of the most common causes of pain-related disability worldwide. There are growing recommendations to use psychological approaches in the management of chronic low back pain. Pain education intervention is one such psychological approach aiming at re-conceptualizing pain beliefs and easing the pain threat value. This randomized controlled trial aimed to gain an understanding of the effectiveness of pain education on pain levels, disability, quality of life, and self-efficacy in individuals with chronic low back pain (CLBP). Methods A two-arm parallel randomized trial was conducted recruiting 92 participants with CLBP, who were randomly allocated to either standard physiotherapy care with the pain education program, or the control group, and both groups received 6 weeks of intervention. Pain intensity (using NPRS), disability (using RMDQ), self-efficacy (using general self-efficacy scale), and wellbeing (using WHO 5I) were assessed before, and 6 weeks after the study intervention. Findings The post-intervention scores comparison between the groups showed that the pain education intervention reduced disability compared to the usual standard care at 6 weeks (mean difference 8.2, p < 0.001, effect size η2 = 0.75), the pain intensity (mean difference 3.5, p < 0.001, effect size η2 = 0.82) and improved the wellbeing index (mean difference 13.7, p < 0.001, effect size η2 = 0.58). Conclusion The findings suggested that pain education program enhance the therapeutic benefits of usual standard physiotherapy care among participants with chronic LBP. We conclude that pain education seems to have clinical benefits when delivered along with standard care physiotherapy during the management of chronic low back pain. CTRI registration code CTRI/2021/08/035963 ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial CTRI/2021/08/035963 ### Clinical Protocols ### Funding Statement The author(s) received no specific funding for this work. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The protocol of the trial was approved by the Institutional Ethics Committee of SKIMS vide RP/114/2021 and was registered with the clinical trial registry of India (CTRI/2021/08/035963). All the methods of this trial were carried out in accordance with Declaration of Helsinki. The patient information sheet containing the details of the trial with purpose, benefits, and possible risks were distributed to eligible participants. Written consent was obtained by the data collectors from all the participants. Information was recorded anonymously and confidentiality and beneficence were assured throughout the study period. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All the data supporting the findings of this trial is presented and the full dataset are available from the principal investigator on request.