背景:预制足部矫形器用于治疗慢性非特异性下腰痛,然而,它们的有效性和潜在的作用机制尚不清楚。该研究的主要目的是研究预制足部矫形装置在52周内减轻慢性非特异性下腰痛患者疼痛和改善功能的有效性。
方法:本研究的参与者和评估者是盲目的,平行组,优势随机(1:1)对照试验。该研究将招募60名年龄在18至65岁之间患有慢性非特异性下腰痛的参与者。参与者将随机分为对照组(TheBackBook)或干预组(预制足部矫形器和TheBackBook)。主要结果指标是疼痛和功能从基线到12(主要时间点)的变化,26、52周。次要结果指标包括:从基线到12周的臀中肌活动和腹横肌厚度,12、26和52周的体力活动,以及足部类型与疼痛和功能变化之间的相关性。每天和每周佩戴预制矫形器的小时数,还有,不良事件将由参与者自我报告.将使用意向治疗原则分析数据。
结论:该试验将主要评估预制足部矫形装置在52周内减轻慢性非特异性下腰痛患者疼痛和改善功能的有效性。预计这项研究将使临床医生和研究人员了解预制足部矫形器在治疗慢性非特异性下腰痛方面的作用以及潜在的作用机制。以及脚型是否会影响结果。
背景:ACTRN12618001298202。
BACKGROUND: Prefabricated foot orthoses are used to treat chronic nonspecific low back pain, however their effectiveness and potential mechanism of action is unclear. The primary aims of the
study are to investigate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52 weeks.
METHODS: This
study is a participant and assessor blinded, parallel-group, superiority randomised (1:1) controlled
trial. The
study will recruit 60 participants aged 18 to 65 years with chronic nonspecific low back pain. Participants will undergo randomisation to a control group (The Back Book) or an intervention group (prefabricated foot orthoses and The Back Book). The primary outcome measures will be change in pain and function from baseline to 12 (primary time point), 26, and 52 weeks. Secondary outcome measures include: gluteus medius muscle activity and transversus abdominis muscle thickness from baseline to 12 weeks, physical activity over 12, 26, and 52 weeks, and correlation between foot type and change in measures of pain and function. Number of hours per day and week that the prefabricated orthoses are worn, as well as, adverse events will be self-reported by participants. Data will be analysed using the intention-to-treat principle.
CONCLUSIONS: This
trial will primarily evaluate the effectiveness of prefabricated foot orthotic devices for reducing pain and improving function in people with chronic nonspecific low back pain over 52 weeks. It is expected that this study will provide clinicians and researchers with an understanding of the role that prefabricated foot orthoses may have in the treatment of chronic nonspecific low back pain and a potential mechanism of action, and whether foot type influences the outcome.
BACKGROUND: ACTRN12618001298202.