Bifidobacterium治疗慢性腰部疼痛的Modic变化的患者:多中心,随机,安慰剂对照试验的研究方案
Sunqi Nian1,2, Chengjin Li1, Na Li3
1The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, China.
Trials
|September 24, 2025
概括
这项研究调查了Bifidobacterium adolescentis (BA) 是否可以通过Modic改变治疗慢性腰部疼痛 (LBP). 研究人员的目标是,在三个月的时间里,与安慰剂相比,BA是否能减少疼痛和残疾.
科学领域:
- 整形外科和康复治疗
- 微生物组研究 微生物组研究
- 疼痛管理 疼痛管理
背景情况:
- 腰部疼痛 (LBP) 是一个普遍的全球健康问题,在MRI上Modic变化 (MCs) 与椎间盘退化 (IDD) 有关.
- 在IDD和MCs患者中观察到Bifidobacterium属的水平降低,这表明在LBP中可能发挥作用.
- 较低Bifidobacterium和MC相关的LBP之间的特定联系需要进一步调查.
研究的目的:
- 与安慰剂相比,评估口服Bifidobacterium adolescentis (BA) 在治疗与Modic变化 (MCs) 相关的慢性腰部疼痛 (LBP) 中的疗效.
- 探索BA作为与磁盘退化相关的LBP的新疗法战略的潜力.
主要方法:
- 一个多中心,双盲,随机,安慰剂对照试验,涉及慢性LBP和Modic I或II型患者.
- 参与者接受了口服Bifidobacterium青少年或安慰剂,每天两次,为期三个月.
- 主要结局:简体中文罗兰·莫里斯残疾问卷 (SCRMDQ) 在3,6和12个月的得分变化;次要结局包括DASS-21,MRI,骨密度和生物标志物.
主要成果:
- 该部分尚未提供,因为研究仍在进行中.
结论:
- 这项临床试验预计将为治疗慢性腰部疼痛的Bifidobacterium adolescentis的治疗益处提供重要的见解.
- 这些发现可能支持LBP的新治疗途径,特别是涉及Modic变化和潜在微生物群失调的病例.
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