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首页> 外文期刊>International Journal of Biometeorology: Journal of the International Society of Biometeorology >One-year follow-up of mud-bath therapy in patients with bilateral knee osteoarthritis: a randomized, single-blind controlled trial
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One-year follow-up of mud-bath therapy in patients with bilateral knee osteoarthritis: a randomized, single-blind controlled trial

机译：双侧膝骨关节炎患者泥浴疗法的一年随访：一项随机，单盲对照试验

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The objective of this prospective parallel randomized single-blind study was to assess that a cycle of mud-bath therapy (MBT) provides any benefits over usual treatment in patients with bilateral knee osteoarthritis (OA). Patients with symptomatic primary bilateral knee OA, according to ACR criteria, were included in the study and randomized to one of two groups: one group received a cycle of MBT at spa center of Chianciano Terme (Italy) in addition to the usual treatment, and one group continued their regular care routine alone. Clinical assessments were performed 7 days before enrollment (screening visit), at the time of enrollment (basal time), after 2 weeks, and after 3, 6, 9, and 12 months after the beginning of the study. All assessments were conducted by two researchers blinded to treatment allocation. The primary efficacy outcomes were the global pain score evaluated by Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscore for physical function (W-TPFS). Of the 235 patients screened, 103 met the inclusion criteria: 53 patients were included in the MBT group and 50 in the control group. In the group of patients treated with MBT, we observed a statistically significant (p 0.001) reduction of VAS and W-TPFS score at the end of the treatment; this improvement was significant (p0.05) also at 3 months of follow-up. The control group did not show significant differences between baseline time and all other times. The differences between one group were significant for both primary parameters already from the 15th day and persisted up to the 9th month. This beneficial effect was confirmed by the significant reduction of symptomatic drug consumption. Tolerability of MBT seemed to be good, with light and transitory side effects. Our results confirm that a cycle of MBT added to usual treatment provides a beneficial effect on the painful symptoms and functional capacities in patients with knee OA that lasts over time. Mud-bath therapy can represent a useful backup to pharmacologic treatment of knee OA or a valid alternative for patients who do not tolerate pharmacological treatments.
机译：这项前瞻性平行随机单盲研究的目的是评估双侧膝骨关节炎（OA）患者的泥浴疗法（MBT）周期与常规治疗相比有什么好处。根据ACR标准，有症状的原发性双侧膝OA患者被纳入研究，并随机分为两组之一：一组除常规治疗外，在Chianciano Terme（意大利）的spa中心接受了MBT周期治疗;一组仅继续常规护理。在入选前7天（筛查访视），入选时（基础时间），研究开始后2周后以及3、6、9和12个月后进行临床评估。所有评估均由两名对治疗分配不知情的研究人员进行。主要疗效指标是通过视觉模拟量表（VAS）和西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评估的身体功能（W-TPFS）评估的总体疼痛评分。在筛查的235例患者中，有103例符合纳入标准：MBT组中包括53例患者，对照组中50例。在接受MBT治疗的患者组中，我们观察到治疗结束时VAS和W-TPFS评分的降低具有统计学意义（p <0.001）;在随访的3个月中，这种改善也是显着的（p <0.05）。对照组在基线时间和所有其他时间之间没有显示出显着差异。两组之间的差异从第15天开始就一直存在，并且一直持续到第9个月。通过明显减少对症药物的消耗，可以确认这种有益效果。 MBT的耐受性似乎很好，并具有轻度和短暂的副作用。我们的结果证实，在常规治疗中添加MBT周期可对膝OA患者的疼痛症状和功能能力产生有益的影响，这种症状会持续一段时间。泥浴疗法可以作为膝盖OA药理学治疗的有用后盾，或者是对不能耐受药理学治疗的患者的有效替代方案。

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