Faculté de médecine, Université Laval, Quebec, Quebec, Canada.
CIRRIS, Quebec, Quebec, Canada.
BMJ Open. 2021 Mar 24;11(3):e045504. doi: 10.1136/bmjopen-2020-045504.
INTRODUCTION: While multiple pharmacological and non-pharmacological interventions treating chronic non-specific low back pain (CLBP) are available, they have been shown to produce at best modest effects. Interventions such as repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, have exhibited promising results to alleviate chronic pain. However, evidence on the effectiveness of rTMS for CLBP is scarce due to limited rigorous clinical trials. Combining rTMS with motor control exercises (MCE) may help to address both central and nociceptive factors contributing to the persistence of LBP. The primary aim of this randomised controlled trial is to compare the effectiveness of a combination of rTMS and MCE to repeated rTMS sessions alone, sham rTMS and a combination of sham rTMS and MCE on pain intensity. METHODS AND ANALYSIS: One hundred and forty participants (35/group) with CLBP will be randomised into four groups (active rTMS+MCE, sham rTMS+MCE, active rTMS and sham rTMS) to receive 10 sessions of their allocated intervention. The primary outcome will be the pain intensity, assessed at baseline, 4, 8, 12 and 24 weeks. Secondary outcomes will include disability, fear of movement, quality of life and patient global rating of change. ETHICS AND DISSEMINATION: Ethics approval was obtained from the in June 2019 (#2020-1844 - CER CIUSSS-CN). The results of the study will be submitted to a peer-reviewed journal and scientific meetings. TRIAL REGISTRATION NUMBER: NCT04555278.
简介:虽然有多种药物和非药物干预措施可用于治疗慢性非特异性下腰痛(CLBP),但它们的效果最多也只是适度的。重复经颅磁刺激(rTMS)等非侵入性脑刺激形式已显示出缓解慢性疼痛的有前景的结果。然而,由于严格的临床试验有限,rTMS 治疗 CLBP 的有效性证据仍然不足。将 rTMS 与运动控制练习(MCE)结合使用可能有助于解决导致 LBP 持续存在的中枢和伤害感受因素。本随机对照试验的主要目的是比较 rTMS 和 MCE 的联合治疗与重复 rTMS 治疗、假 rTMS 治疗以及假 rTMS 和 MCE 的联合治疗对疼痛强度的效果。 方法和分析:140 名 CLBP 患者(每组 35 名)将被随机分为四组(主动 rTMS+MCE、假 rTMS+MCE、主动 rTMS 和假 rTMS),接受 10 次分配的干预。主要结局将是疼痛强度,在基线、4、8、12 和 24 周进行评估。次要结局将包括残疾、运动恐惧、生活质量和患者整体变化的总体评价。 伦理和传播:2019 年 6 月,该研究获得了[机构名称]的伦理批准(#2020-1844 - CER CIUSSS-CN)。该研究的结果将提交给同行评审的期刊和科学会议。 试验注册号:NCT04555278。
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