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一项关于水电泳疗法对慢性下腰痛患者急性复发疗效的随机对照试验。

A randomised controlled trial on the efficacy of hydroelectrophoresis in acute recurrences in chronic low back pain patients.

作者信息

Brizzi A, Giusti A, Giacchetti P, Stefanelli S, Provinciali L, Ceravolo M G

机构信息

Department of Neuroscience, Azienda Ospedali Riuniti di Ancona, Polytechnic University of Marche, Italy.

出版信息

Eura Medicophys. 2004 Dec;40(4):303-9.

PMID:16175155
Abstract

AIM

Physical therapy efficacy in the treatment of low back pain (LBP) has been widely debated and is far from achieving high levels of evidence. Hydroelectrophoresis (Hydrofor) is a novel method of driving drugs through the dermal tissue, which has been proposed for muscle pain treatment. Aim of this randomised placebo-controlled study was to ascertain the efficacy of Hydrofor treatment on acute relapsing episodes of pain in chronic LBP subjects.

METHODS

Eighteen under-50 adults (M/F: 7/11; age 35+/-8 years) suffering from chronic LBP were enrolled within 3 to 4 days of back pain relapse. After a complete clinical and functional assessment patients were randomly divided into 2 equal groups. Group A received 3 Hydrofor applications of a mixture containing both NSAIDs and muscle relaxants, whereas Group B received 3 Hydrofor applications of a drug-free solution. Afterwards, both groups performed the same rehabilitation treatment consisting of 7 group sessions of standard physiotherapy, including stretching, range of motion and extension exercises. The Oswestry disability index (ODI), the Million instrument scale and a visual analogue scale (VAS) were chosen as outcome measures and applied at baseline, after Hydrofor/placebo applications, after completion of rehabilitation sessions and, at last, 2 months later. The two-way Friedman test was used to analyse within-group (time effect) and between-group (time x group effect) differences.

RESULTS

All subjects declared a significant pain reduction since the first Hydrofor application. Pain evolution overlapped in the 2 groups until the 3rd session, after which Group A significantly diverged from Group B, as they affirmed a greater symptom reduction than controls (time x group effect: VAS: F = 7.4, p <0.01). Such difference disappeared after the physiotherapy sessions as well as 2 months later (time x group effect: VAS: F = 2.1, p =0.08). Pain-related disability showed a greater reduction in Group A than B immediately after Hydrofor application (time x group effect: ODI: F=3.9 p <0.05; Million: F=4.1 p<0.05), but the mean scores almost overlapped at the 2 month follow-up (time x group effect: ODI: F=2.3 p =0.08; Million: F=1.3 p=0.26).

CONCLUSIONS

Hydrofor treatment relieves relapsing LBP and could be recommended to active adults as a safe technique shortening the time needed to achieve functional restoration.

摘要

目的

物理治疗在腰痛(LBP)治疗中的疗效一直存在广泛争议,且远未达到高水平的证据。水电泳疗法(Hydrofor)是一种通过真皮组织驱动药物的新方法,已被提议用于肌肉疼痛治疗。本随机安慰剂对照研究的目的是确定Hydrofor治疗对慢性腰痛患者急性复发性疼痛发作的疗效。

方法

18名年龄在50岁以下(男/女:7/11;年龄35±8岁)的慢性腰痛患者在背痛复发的3至4天内入组。在进行全面的临床和功能评估后,患者被随机分为两组。A组接受3次Hydrofor治疗,使用含有非甾体抗炎药和肌肉松弛剂的混合物,而B组接受3次Hydrofor治疗,使用无药物溶液。之后,两组都进行相同的康复治疗,包括7次标准物理治疗小组课程,包括拉伸、活动范围和伸展运动。选择Oswestry功能障碍指数(ODI)、Million量表和视觉模拟量表(VAS)作为疗效指标,并在基线、Hydrofor/安慰剂治疗后、康复课程结束后以及最后2个月后应用。采用双向Friedman检验分析组内(时间效应)和组间(时间×组效应)差异。

结果

所有受试者均表示自首次应用Hydrofor治疗后疼痛显著减轻。两组的疼痛进展在第3次治疗前重叠,此后A组与B组明显不同,因为他们确认症状减轻程度大于对照组(时间×组效应:VAS:F = 7.4,p <0.01)。这种差异在物理治疗课程结束后以及2个月后消失(时间×组效应:VAS:F = 2.1,p = 0.08)。在应用Hydrofor治疗后,A组与疼痛相关的功能障碍比B组有更大程度的减轻(时间×组效应:ODI:F = 3.9,p <0.05;Million:F = 4.1,p <0.05),但在2个月随访时平均得分几乎重叠(时间×组效应:ODI:F = 2.3,p = 0.08;Million:F = 1.3,p = 0.26)。

结论

Hydrofor治疗可缓解复发性腰痛,对于活跃的成年人,可作为一种安全的技术推荐使用,它能缩短实现功能恢复所需的时间。

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