School of Rehabilitation, University of Shebrooke, Sherbrooke, Quebec, Canada.
Faculty of Medecine, Laval University, Quebec, Quebec, Canada.
PLoS One. 2021 Jan 20;16(1):e0245689. doi: 10.1371/journal.pone.0245689. eCollection 2021.
Self-reported levels of disability in individuals with low back pain (LBP) have not improved in the last decade. A broader perspective and a more comprehensive management framework may improve disability outcomes. We recently developed and validated the Low Back Pain and Disability Drivers Management (PDDM) model, which aims to identify the domains driving pain and disability to guide clinical decisions. The objectives of this study were to determine the applicability of the PDDM model to a LBP population and the feasibility of conducting a pragmatic trial, as well as to explore clinicians' perceived acceptability of the PDDM model's use in clinical settings.
This study was an one-arm prospective feasibility trial. Participants included physiotherapists working with a population suffering from LBP and their patients aged 18 years or older presenting with a primary complaint of LBP that sought a new referral and deemed fit for rehabilitation from private and public clinical settings. Clinicians participated in a one-day workshop on the integration of the PDDM model into their clinical practice, and were asked to report various LBP-related outcomes via self-reported questionnaires (i.e., impact of pain on physical function, nervous system dysfunctions, cognitive-emotional factors, work disabilities) at baseline and at six-week follow-up. Physiotherapists' acceptability of the use of the PDDM model and appreciation of the training were assessed via semi-structured phone interviews. Analyses focused on a description of the model's applicability to a LBP population, feasibility outcomes and acceptability measures.
Applicablity of the PDDM model was confirmed since it successfully established the profile of patients according to the elements of each categories, and each of the 5 domains of the model was represented among the study sample. Trial was deemed feasible contingent upon few modifications as our predefined success criteria for the feasibility outcomes were met but feasibility issues pertaining to data collection were highlighted. Twenty-four (24) clinicians and 61 patients were recruited within the study's timeframe. Patient's attrition rate (29%) and clinicians' compliance to the study protocol were adequate. Clinicians' perceived acceptability of the use of the model in clinical settings and their appreciation of the training and online resources were both positive. Recommendations to improve the model's integration in clinical practice, content of the workshop and feasibility of data collection methods were identified for future studies. A positive effect for all patients' reported outcome measures were also observed. All outcome measures except for the PainDetect questionnaire showed a statistically significant reduction post-intervention (p<0.05).
These findings provide preliminary evidence of the potential of the PDDM model to optimize LBP management as well as conducting a future larger-scale pragmatic trial to determine its effectiveness.
Clinicaltrial.gov: NCT03949179.
在过去的十年中，患有下腰痛（LBP）的个体的自我报告残疾水平并没有改善。更广阔的视角和更全面的管理框架可能会改善残疾的结果。我们最近开发并验证了下腰痛和残疾驱动因素管理（PDDM）模型，旨在确定导致疼痛和残疾的领域，以指导临床决策。本研究的目的是确定 PDDM 模型是否适用于 LBP 人群，以及进行实用试验的可行性，并探讨临床医生对 PDDM 模型在临床环境中使用的可接受性。
这是一项单臂前瞻性可行性试验。参与者包括在私人和公共临床环境中与患有 LBP 的人群一起工作的物理治疗师及其年龄在 18 岁或以上的患有原发性 LBP 抱怨的患者，他们寻求新的转诊并适合康复。临床医生参加了为期一天的研讨会，内容是将 PDDM 模型整合到他们的临床实践中，并要求他们通过自我报告的问卷报告各种与 LBP 相关的结果（即疼痛对身体功能的影响、神经系统功能障碍、认知情感因素、工作障碍）在基线和 6 周随访时。通过半结构化电话访谈评估物理治疗师对使用 PDDM 模型的可接受性以及对培训的欣赏程度。分析重点是模型在 LBP 人群中的适用性、可行性结果和可接受性措施。
PDDM 模型的适用性得到了确认，因为它成功地根据每个类别的元素建立了患者的个人资料，并且研究样本中代表了模型的 5 个领域中的每一个。试验被认为是可行的，因为我们的可行性结果的预定成功标准得到了满足，但强调了与数据收集相关的可行性问题。在研究时间范围内，共招募了 24 名临床医生和 61 名患者。患者的流失率（29%）和临床医生对研究方案的依从性都足够。临床医生对在临床环境中使用该模型的可接受性以及他们对培训和在线资源的欣赏都是积极的。为未来的研究确定了改进模型在临床实践中的整合、研讨会的内容和数据收集方法的可行性的建议。还观察到所有患者报告的结果测量指标的积极影响。除了 PainDetect 问卷外，所有其他结果测量指标在干预后均显示出统计学上的显著降低（p<0.05）。
这些发现提供了初步证据，表明 PDDM 模型有可能优化 LBP 管理，并进行未来更大规模的实用试验以确定其有效性。
Clinicaltrial.gov：NCT03949179。
