School of Rehabilitation, University of Sherbrooke, Sherbrooke, Quebec, Canada.
Research Centre of the Centre Hospitalier Universitaire de Sherbrooke, Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie, Sherbrooke, Quebec, Canada.
Musculoskeletal Care. 2023 Sep;21(3):667-682. doi: 10.1002/msc.1738. Epub 2023 Feb 7.
Low back pain (LBP) remains the leading cause of disability. The Low Back Pain and Disability Drivers Management (PDDM) model aims to identify the domains driving pain and disability to guide clinical decisions. The objectives of this study were to determine the feasibility of conducting a pragmatic controlled trial of the PDDM model and to explore its effectiveness compared to clinical practice guidelines' recommendations for LBP management.
A pilot cluster nonrandomised controlled trial. Participants included physiotherapists and their patients aged 18 years or older presenting with a primary complaint of LBP. Primary outcomes were the feasibility of the trial design. Secondary exploratory analyses were conducted on LBP-related outcomes such as pain severity and interference at 12-week follow-up.
Feasibility of study procedures were confirmed, recruitment exceeded our target number of participants, and the eligibility criteria were deemed suitable. Lost to follow-up at 12 weeks was higher than expected (43.0%) and physiotherapists' compliance rates to the study protocol was lower than our predefined threshold (75.0% vs. 57.5%). A total of 44 physiotherapists and 91 patients were recruited. Recommendations for a larger scale trial were formulated. The PDDM model group demonstrated slightly better improvements in all clinical outcome measures compared to the control group at 12 weeks.
The findings support the feasibility of conducting such trial contingent upon a few recommendations to foster proper future planning to determine the effectiveness of the PDDM model. Our results provide preliminary evidence of the PDDM model effectiveness to optimise LBP management.
Clinicaltrial.gov, NCT04893369.
下腰痛(LBP)仍然是导致残疾的主要原因。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对 PDDM 模型进行实用对照试验的可行性,并探索其与腰痛管理临床实践指南建议相比的有效性。
一项试点性非随机对照试验。参与者包括物理治疗师及其年龄在 18 岁或以上、因原发性腰痛就诊的患者。主要结局是试验设计的可行性。次要探索性分析在 12 周随访时进行,分析的结果是与 LBP 相关的结果,如疼痛严重程度和干扰。
研究程序的可行性得到了确认,招募人数超过了我们的目标人数,且符合入选标准。12 周时失访率高于预期(43.0%),物理治疗师对研究方案的遵守率低于我们规定的阈值(75.0%比 57.5%)。共招募了 44 名物理治疗师和 91 名患者。制定了更大规模试验的建议。与对照组相比,PDDM 模型组在所有临床结局测量上的改善稍好。
这些发现支持进行此类试验的可行性,但需要一些建议,以促进未来的适当规划,从而确定 PDDM 模型的有效性。我们的研究结果初步证明了 PDDM 模型对优化腰痛管理的有效性。
Clinicaltrial.gov,NCT04893369。