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一项比较椎体解压术与保守治疗对疼痛性椎体压缩性骨折的随机对照试验。

A Randomized Controlled Trial of Vertebral Body Decompression Procedure Versus Conservative Treatment for Painful Vertebral Compression Fracture.

机构信息

Spine Center and Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si 13620, Republic of Korea.

出版信息

Medicina (Kaunas). 2023 Oct 17;59(10):1848. doi: 10.3390/medicina59101848.

DOI:10.3390/medicina59101848
PMID:37893566
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10608657/
Abstract

Traditional treatment modalities for vertebral compression fractures (VCFs) include bed rest, pain medications, muscle relaxants, back braces, and physical therapy. In cases where conservative treatment proves ineffective, a new procedure called core decompression of the vertebral body is explored. Core decompression of the vertebral body has the potential to lower and stabilize the intraosseous pressure, resulting in enhanced blood circulation, which contributes to pain reduction. In this trial, we evaluated the efficacy of core decompression of the vertebral body in patients with painful VCFs compared with conventional conservative treatment. This prospective randomized controlled trial was conducted at a tertiary education hospital between June 2017 and May 2020. The participants were randomly assigned in a 1:1 ratio to one of two treatment groups: the core decompression group and the conservative treatment group. The primary outcome measure was the visual analog scale (VAS) pain score of the back 3 months after the procedure. Secondary outcome measures included the Oswestry Disability Index (ODI) for lumbar disabilities, the European Quality of Life-5 Dimensions (EQ-5D) score for quality of life, and radiographic outcomes such as changes in compression rate. All patients underwent the assigned intervention (48 core decompression and 50 conservative treatments). At both 1 month and 3 months, there were no significant differences between the core decompression group and conservative treatment group in VAS pain score (adjusted treatment effect: -0.1 and 2.0; 95% confidence interval [CI]: -7.5 to 7.3 and -5.6 to 9.6; = 0.970 and = 0.601, respectively). In addition, there were no significant inter-group differences in ODI and EQ-5D scores throughout the follow-up period ( = 0.917 and 0.704, respectively). Core decompression of the vertebral body did not demonstrate any significant improvement in pain and disability compared to conventional conservative treatment.

摘要

传统的椎体压缩性骨折(VCF)治疗方法包括卧床休息、止痛药、肌肉松弛剂、背部支架和物理治疗。在保守治疗无效的情况下,会探索一种新的方法,即椎体的核心减压。椎体的核心减压有可能降低并稳定骨内压,从而增加血液循环,有助于减轻疼痛。在这项试验中,我们评估了椎体核心减压与传统保守治疗相比在治疗疼痛性 VCF 患者方面的疗效。这是一项在 2017 年 6 月至 2020 年 5 月期间在一家三级教育医院进行的前瞻性随机对照试验。参与者按照 1:1 的比例随机分配到两个治疗组之一:核心减压组和保守治疗组。主要结局测量指标是术后 3 个月时背部的视觉模拟量表(VAS)疼痛评分。次要结局测量指标包括腰椎功能障碍的 Oswestry 残疾指数(ODI)、生活质量的欧洲生活质量-5 维度(EQ-5D)评分以及压缩率变化等影像学结果。所有患者均接受了指定的干预措施(48 例核心减压和 50 例保守治疗)。在 1 个月和 3 个月时,核心减压组和保守治疗组之间的 VAS 疼痛评分没有显著差异(调整治疗效果:-0.1 和 2.0;95%置信区间[CI]:-7.5 至 7.3 和-5.6 至 9.6;=0.970 和=0.601,分别)。此外,在整个随访期间,ODI 和 EQ-5D 评分均无显著组间差异(=0.917 和 0.704,分别)。与传统保守治疗相比,椎体核心减压并未在疼痛和残疾方面显示出任何显著改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47d7/10608657/b6ccfd250dce/medicina-59-01848-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47d7/10608657/f4552ce9c591/medicina-59-01848-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47d7/10608657/153b42c6677d/medicina-59-01848-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47d7/10608657/b6ccfd250dce/medicina-59-01848-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47d7/10608657/f4552ce9c591/medicina-59-01848-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47d7/10608657/153b42c6677d/medicina-59-01848-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47d7/10608657/b6ccfd250dce/medicina-59-01848-g003.jpg

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