Calmels Paul, Queneau Patrice, Hamonet Claude, Le Pen Claude, Maurel Frederique, Lerouvreur Claire, Thoumie Philippe
Service de Médecine Physique et Réadaptation, Université Jean Monnet, Hôpital Bellevue, Saint Etienne, France.
Spine (Phila Pa 1976). 2009 Feb 1;34(3):215-20. doi: 10.1097/BRS.0b013e31819577dc.
Multicentric, randomized, and controlled study of clinical evaluation of medical device in subacute low back pain.
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.
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.
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.
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).
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.
多中心、随机、对照研究,评估医疗器械在亚急性下背痛中的临床效果。
评估弹性腰带来治疗下背痛时,对功能能力、疼痛强度的影响以及对医疗成本的益处。
关于腰托治疗下背痛有效性的证据有限。报道该器械有效性的研究中也缺乏相应方法。
本研究为随机、多中心、对照研究,分为两组:使用腰带治疗的患者组(BWG)和对照组(CG)。临床评估的主要标准是用EIFEL量表评估身体恢复情况,用视觉模拟量表评估疼痛程度,主要经济标准是相关医疗治疗的总成本。
197名患者参与了研究。结果显示,在第0天至第90天期间,BWG组的EIFEL评分下降幅度高于CG组(7.6±4.4对6.1±4.7;P = 0.023)。视觉模拟量表评分也有显著下降(41.5±21.4对32.0±20;P = 0.002)。在第90天,药物消耗减少(BWG组未服用任何药物的患者比例为60.8%,CG组为40%;P = 0.029)。
在亚急性下背痛中佩戴腰带可显著改善功能状态、疼痛程度和药物消耗。本研究可能有助于强调腰托作为下背痛治疗中除传统药物治疗外的一种补充性非药物治疗方法的价值。