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

ABSTRACT: BACKGROUND:The 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. METHODS:The 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. DISCUSSION:The 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 DISSEMINATION:Ethics 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.

SUBMITTER: Silva FG

PROVIDER: S-EPMC7594364 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Silva Fernanda Gonçalves FG Mota da Silva Tatiane T Palomo Gabriele Alves GA Hancock Mark Jonathan MJ Costa Lucíola da Cunha Menezes LDCM Costa Leonardo Oliveira Pena LOP

BMJ open 20201028 10

<h4>Background</h4>The 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.<h4>Me ...[more]

PMID: 33115905

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Project description:IntroductionExercise therapy is the most recommended treatment for chronic low back pain (LBP). Effect sizes for exercises are usually small to moderate and could be due to the heterogeneity of people presenting with LBP. Thus, if patients could be better matched to exercise based on individual factors, then the effects of treatment could be greater. A recently published study provided evidence of better outcomes when patients are matched to the appropriate exercise type. The study demonstrated that a 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to one of the two exercise approaches for LBP (motor control and graded activity). The primary aim of the current study isill be to evaluate whether preidentified baseline characteristics, including the LSIQ, can modify the response to two of the most common exercise therapies for non-specific LBP. Secondary aims include an economic evaluations with a cost-effectiveness analysis.Methods and analysisParticipants (n=414) will be recruited by primary care professionals and randomised (1:1) to receive motor control exercises or graded activity. Participants will undergo 12 sessions of exercise therapy over an 8-week period. The primary outcome will be physical function at 2 months using the Oswestry Disability Index. Secondary outcomes will be pain intensity, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitisation. We will construct linear mixed models with terms for participants (fixed), treatment group, predictor (potential effect modifier), treatment group×predictor (potential effect modifier), physiotherapists, treatment group×physiotherapists and baseline score for the dependent variable.Ethics and disseminationThis study received ethics approval from the Hamilton Integrate Research Ethics Board. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04283409.

Project description:BackgroundAdequate pain assessment is critical for evaluating the efficacy of analgesic treatment in clinical practice and during the development of new therapies. Yet the currently used scores of global pain intensity fail to reflect the diversity of pain manifestations and the complexity of underlying biological mechanisms. We have developed a tool for a standardized assessment of pain-related symptoms and signs that differentiates pain phenotypes independent of etiology.Methods and findingsUsing a structured interview (16 questions) and a standardized bedside examination (23 tests), we prospectively assessed symptoms and signs in 130 patients with peripheral neuropathic pain caused by diabetic polyneuropathy, postherpetic neuralgia, or radicular low back pain (LBP), and in 57 patients with non-neuropathic (axial) LBP. A hierarchical cluster analysis revealed distinct association patterns of symptoms and signs (pain subtypes) that characterized six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain. Using a classification tree analysis, we identified the most discriminatory assessment items for the identification of pain subtypes. We combined these six interview questions and ten physical tests in a pain assessment tool that we named Standardized Evaluation of Pain (StEP). We validated StEP for the distinction between radicular and axial LBP in an independent group of 137 patients. StEP identified patients with radicular pain with high sensitivity (92%; 95% confidence interval [CI] 83%-97%) and specificity (97%; 95% CI 89%-100%). The diagnostic accuracy of StEP exceeded that of a dedicated screening tool for neuropathic pain and spinal magnetic resonance imaging. In addition, we were able to reproduce subtypes of radicular and axial LBP, underscoring the utility of StEP for discerning distinct constellations of symptoms and signs.ConclusionsWe present a novel method of identifying pain subtypes that we believe reflect underlying pain mechanisms. We demonstrate that this new approach to pain assessment helps separate radicular from axial back pain. Beyond diagnostic utility, a standardized differentiation of pain subtypes that is independent of disease etiology may offer a unique opportunity to improve targeted analgesic treatment.

Project description:IntroductionThis protocol describes the methods for a mixed study systematic review aiming to explore the definitions and measurements of recovery in patients with low back pain, and how perspectives of recovery differ between patients and providers. This review will be the first to review the concept of recovery in patients with low back pain across both quantitative and qualitative literature.Methods and analysisThis protocol has been designed and reported in line with Preferred Reporting Items of Systematic Reviews and Meta-Analyses Protocols. The following databases will be electronically searched from database inception until 30 November 2021: Medline, EMBASE, CINAHL, Cochrane, PEDro. Grey literature will be searched for through targeted searching of ProQuest Dissertations and Theses and handsearching of the references of all included studies. Studies will be included if they include a patient population of >50% with low back pain (with or without leg pain), and mention the concept of recovery within the abstract, methods or results. The Mixed Methods Appraisal Tool will be used for quality assessment of both quantitative and qualitative included studies. Two independent reviewers will conduct the search, screen titles/abstracts and extract relevant data from full texts. Discrepancies between reviewers will be settled by a third reviewer with spinal pain expertise. For syntheses, thematic analysis will be used to analyse both qualitative and quantitative investigations to explore meanings, measurement and perspectives of recovery from a diverse evidence base. There is no clinical trial associated with this protocol.Ethics and disseminationThere are no ethical issues associated with this systematic review, and ethics approval was not required. Once completed, the results of this review will be published in a peer-reviewed journal within the realm of spinal pain to help guide future research inquiries.Prospero registration numberCRD42022295804.

Project description:There is a consensus that exercise therapy should be used as a therapeutic approach in chronic low back pain (CLBP) but little consensus has been reached about the preferential type of therapy. Due to the heterogeneity of the population no clear effect of specific therapy interventions are found. Probably a specific subgroup of the investigated population will benefit from the intervention and another subgroup will not benefit, looking at the total investigated population no significant effects can be found. Therefore there is a need for the development of clinical prediction rules (CPRs). Objectives for this trial are first, the derivation of CPRs to predict treatment response to three forms of exercise therapy for patients with nonspecific CLBP. Secondly, we aim to validate a CPR for the three forms of exercise therapy for patients with nonspecific CLBP.The study design is a randomized controlled trial. Patients with nonspecific CLBP of more than three months duration are recruited at the Antwerp University Hospital (Belgium) and Apra Rehabilitation Hospital. After examination, patients are randomly assigned to one of three intervention groups: motor control therapy, general active exercise therapy and isometric training therapy. All patients will undergo 18 treatment sessions during nine weeks. Measurements will be taken at baseline, nine weeks, six months and at one year. The primary outcome used is the Modified Oswestry Disability Questionnaire score. For each type of exercise therapy a CPR will be derived and validated. For validation, the CPR will be applied to divide each treatment group into two subgroups (matched and unmatched therapy) using the baseline measurements. We predict a better therapeutic effect for matched therapy.A randomized controlled trial has not previously been performed for the development of a CPR for exercise therapy in CLBP patients. Only one CPR was described in a single-arm design for motor control therapy in sub-acute non-radicular LBP patients. In this study, a sufficiently large sample will be included in both the derivation and validation phase.This trial was registered with Clinicaltrials.gov on 10 February 2014, registration number: NCT02063503.

Dataset Information

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

Publications

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

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