Predicting pain recovery in patients with acute low back pain: a study protocol for a broad validation of a prognosis prediction model

• Published in: BMJ open 2020-10, Vol.10 (10), p.e040785-e040785
• Main Authors: Silva, Fernanda Gonçalves, Mota da Silva, Tatiane, Palomo, Gabriele Alves, Hancock, Mark Jonathan, Costa, Lucíola da Cunha Menezes, Costa, Leonardo Oliveira Pena
• Format: Article
• Language: English
• Subjects: adult orthopaedics; Analgesics; Back pain; Brazil; Emergency medical care; Epidemiology; Ethics; Humans; Low Back Pain - diagnosis; Low Back Pain - therapy; Medical prognosis; Metastasis; Models, Statistical; musculoskeletal disorders; Pain Measurement; Patients; Primary care; Prognosis; Prospective Studies; Recovery (Medical); Rehabilitation Medicine; spine; Validation studies; Variables
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2020-040785

BackgroundThe clinical course of acute low back pain (LBP) is generally favourable; however, there is significant variability in the prognosis of these patients. A clinical prediction model to predict the likelihood of pain recovery at three time points for patients with acute LBP has recently been developed. The aim of this study is to conduct a broad validation test of this clinical prediction model, by testing its performance in a new sample of patients and a different setting.MethodsThe validation study with a prospective cohort design will recruit 420 patients with recent onset non-specific acute LBP, with moderate pain intensity, seeking care in the emergency departments of hospitals in São Paulo, Brazil. The primary outcome measure will be days to recovery from pain. The predicted probability of pain recovery for each individual will be computed based on predictions of the development model and this will be used to test the performance (calibration and discrimination) in the validation dataset.DiscussionThe findings of this study will better inform about the performance of the clinical prediction model, helping both clinicians and patients. If the model’s performance is acceptable, then future research should evaluate the impact of the prediction model, assessing whether it produces a change in clinicians’ behaviour and/or an improvement in patient outcomes.Ethics and disseminationEthics were granted by the Research Ethics Committee of the Universidade Cidade de São Paulo, #20310419.4.0000.0064. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.