Effectiveness of a Lumbar Belt in Subacute Low Back Pain An Open, Multicentric, and Randomized Clinical Study
Effectiveness of a Lumbar Belt in Subacute Low Back Pain An Open, Multicentric, and Randomized Clinical Study
复制标题
DOI：
10.1097/brs.0b013e31819577dc
复制
发表时间：
2009-02-01
期刊：
影响因子：
3
通讯作者：
Thoumie, Philippe
中科院分区：
文献类型：
--
作者：
Calmels, Paul;Queneau, Patrice;Thoumie, Philippe
研究设计。亚急性腰痛医疗器械临床评价的多中心随机对照研究。目的：评价弹性腰带在下腰痛治疗中对功能容量、疼痛强度的影响，以及对医疗费用的好处。腰椎支撑治疗下腰痛的有效性的证据有限。关于该装置效率的研究报道也缺乏方法论。本研究采用随机、多中心、对照的方法，分为两组：腰带治疗组(BWG)和对照组(CG)。临床评价的主要标准是Eifel量表评定的身体恢复情况，视觉类比评分评定疼痛程度，主要的经济标准是相关医疗的总费用。已有197名患者参与。结果显示，在第0-90天，体重组的Eifel评分下降幅度高于对照组(7.6%+/-4.4vs.de6.1+/-4.7%；P=0.023)。视觉类比评分明显降低(41.5+/-21.4vs.32.0+/-20；P=0.002)。D90时药物用量减少(BWG组未服用任何药物的患者比例为60.8%，CG组为40%；P=0.029)。腰带佩戴可显著改善亚急性腰背痛患者的功能状态、疼痛程度和药物用量。这项研究可能有助于强调腰椎支持作为一种补充和非药物治疗的兴趣，而不是传统药物治疗下腰痛的用法。
Study Design. Multicentric, randomized, and controlled study of clinical evaluation of medical device in subacute low back pain.Objective. To evaluate the effects of an elastic lumbar belt on functional capacity, pain intensity in low back pain treatment, and the benefice on medical cost.Summary of Background Data. There is limited evidence of efficiency of lumbar supports for treatment of low back pain. There is also a lack of the methodology in the studies reported on the efficiency of this device.Methods. This study is randomized, multicentric, and controlled with 2 groups: a patient group treated with a lumbar belt (BWG) and a control group (CG). The main criteria of clinical evaluation were the physical restoration assessed with the EIFEL scale, the pain assessed by a visual analogic scale, the main economical criteria was the overall cost of associated medical treatments.Results. One hundred ninety-seven patients have participated. The results show a higher decrease in EIFEL score in BWG than CG between days 0 and 90 (7.6 +/- 4.4 vs. de 6.1 +/- 4.7; P = 0.023). Respectively significant reduction in visual analogic scale was also noticed (41.5 +/- 21.4 vs. 32.0 +/- 20; P = 0.002). Pharmacologic consumption decreased at D90 (the proportion of patients who did not take any medication in BWG is 60.8% vs. 40% in CG; P = 0.029).Conclusion. Lumbar belt wearing is consequent in subacute low back pain to improve significantly the functional status, the pain level, and the pharmacologic consumption. This study may be useful to underline the interest of lumbar support as a complementary and nonpharmacologic treatment beside the classic medication use in low back pain treatment.