Static magnetic fields for treatment of fibromyalgia: A randomized controlled trial

Static magnetic fields for treatment of fibromyalgia: A randomized controlled trial
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DOI:
10.1089/107555301300004538
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发表时间:
2001-02-01
影响因子:
2.6
通讯作者:
Gillies, GT
Gillies, GT
中科院分区:
医学4区
文献类型:
--
作者:
Alfano, AP;Taylor, AG;Gillies, GT

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目的:为了测试两种不同配置的静态磁场的有效性,由磁性睡眠垫产生,作为连续疗法,在减少患者疼痛感知和改善纤维肌痛患者的功能状态。设计:随机,安慰剂对照,从1997年11月到1998年12月进行了为期6个月的试验。通过临床转诊和媒体公告招募符合1990年美国流变学学会纤维肌痛标准的成年人,并在大学诊所进行评估。干预措施:功能垫A组中的受试者使用了6个月的垫,该垫提供了全身暴露于低、均匀的负极性静磁场。功能垫B组中的受试者使用了6个月的垫,将其暴露于空间和极性不同的低静磁场中。两个假手术组中的受试者使用与功能垫外观和质地相同但含有非活性磁体的垫;将这些组合并进行分析。结果测量:主要结果是6个月时以下指标的变化评分:功能状态(纤维肌痛影响问卷)、疼痛强度等级、压痛点计数和压痛点疼痛强度评分。各组之间的疼痛强度评分存在显著差异(p = 0.03),功能垫A组在6个月时较基线降低最大。所有四组的压痛点数量均有所下降,但组间差异不显著(p = 0.72)。功能垫组的总压痛点疼痛强度下降幅度最大,但总体差异不显著(p = 0.25)。功能垫组的功能状态改善最大,但组间差异不显著(p = 0.23)。虽然功能垫组在治疗6个月后显示出功能、状态、疼痛强度水平、压痛点计数和压痛点强度的改善,除疼痛强度水平外,这些改善与假手术组或外科护理组的变化没有显著差异。
Objective: To test effectiveness of static magnetic fields of two different configurations, produced by magnetic sleep pads, as adjunctive therapies in decreasing patient pain perception and improving functional status in individuals with fibromyalgia.Design: Randomized, placebo-controlled, 6-month trial conducted from November 1997 through December 1998.Setting and subjects: Adults who met the 1990 American College of Rheumatology criteria for fibromyalgia were recruited through clinical referral and media announcements and evaluated at a university-based clinic.Interventions: Subjects in Functional Pad A group used a pad for 6 months that provided whole-body exposure to a low, uniform static magnetic field of negative polarity. Subjects in the Functional Pad B group used a pad for 6 months that exposed them to a low static magnetic field that varied spatially and in polarity. Subjects in two Sham groups used pads that were identical in appearance and texture to the functional pads but contained inactive magnets; these groups were combined for analysis. Subjects in the Usual Care group continued with their established treatment regimens.Outcome measures: Primary outcomes were the change scores at 6 months in the following measures: functional status (Fibromyalgia Impact Questionnaire), pain intensity ratings, tender point count, and a tender point pain intensity score.Results: There was a significant difference among groups in pain intensity ratings (p = 0.03), with Functional Pad A group showing the greatest reduction from baseline at 6 months. All four groups showed a decline in number of tender points, but differences among the groups were not significant (p = 0.72). The functional pad groups showed the largest decline in total tender point pain intensity, but overall differences were not significant (p = 0.25). Improvement in functional status was greatest in the functional pad groups, but differences among groups were not significant (p = 0.23).Conclusions: Although the functional pad groups showed improvements in functional, status, pain intensity level, tender point count, and tender point intensity after 6 months of treatment, with the exception of pain intensity level these improvements did not differ significantly from changes in the Sham group or in the Usual Care group.