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蒂萨苏利和科洛普泥敷疗法对膝骨关节炎的影响:一项双盲、随机、非劣效对照研究。

The effects of Tiszasüly and Kolop mud pack therapy on knee osteoarthritis: a double-blind, randomised, non-inferiority controlled study.

机构信息

Petz Aladár County Teaching Hospital, Híd u.2., Győr, H-9025, Hungary.

Doctoral School of Clinical Medicine, University of Szeged, Korányi fasor 6., Szeged, H-6720, Hungary.

出版信息

Int J Biometeorol. 2020 Jun;64(6):943-950. doi: 10.1007/s00484-019-01764-4. Epub 2019 Aug 3.

Abstract

The aim of this non-inferiority study was to evaluate and compare the effects of Tiszasüly and Kolop mud pack therapy on pain, function and quality of life in patients with knee osteoarthritis. In this double-blind, randomised, follow-up study, 60 patients with knee osteoarthritis were treated with either Tiszasüly hot mud pack (group 1) or with Kolop hot mud pack (group 2) on 10 occasions for 2 weeks (10 working days). One hundred millimetre visual analogue scale (VAS) for knee pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Lequesne Index for physical function and EuroQoL-5D for quality-of-life measurements were recorded at baseline, at the end of treatment (week 2) and 3 months later (week 12). In both groups, all measured parameters improved significantly from the baseline until the end of treatment and during the follow-up period (p < 0.05). There were no significant differences between the groups in terms of the WOMAC, KOOS, EQ-5D and Lequesne Index at any visits. Knee pain improved in both groups at week 2 and week 12; the only significant difference visible between the groups was at the end of the treatment in favour of the Tiszasüly mud pack group (p = 0.009). Tiszasüly and Kolop mud packs both have a favourable effect on knee pain, physical function and quality of life in patients with knee osteoarthritis. Our results proved non-inferiority of Tiszasüly mud pack.

摘要

本非劣效性研究旨在评估和比较提萨苏利和科洛普泥敷疗法对膝骨关节炎患者疼痛、功能和生活质量的影响。在这项双盲、随机、随访研究中,60 名膝骨关节炎患者接受了提萨苏利热泥敷(第 1 组)或科洛普热泥敷(第 2 组)治疗,每 10 次为一个疗程,共 2 周(10 个工作日)。在基线时、治疗结束时(第 2 周)和 3 个月后(第 12 周),使用 100 毫米视觉模拟量表(VAS)评估膝关节疼痛、西部安大略省和麦克马斯特大学关节炎指数(WOMAC)、膝关节损伤和骨关节炎结果评分(KOOS)、Lequesne 指数用于身体功能和 EuroQoL-5D 用于生活质量测量。在两组中,所有测量参数均从基线开始显著改善,直至治疗结束和随访期间(p<0.05)。在任何就诊时,两组之间的 WOMAC、KOOS、EQ-5D 和 Lequesne 指数均无显著差异。两组的膝关节疼痛均在第 2 周和第 12 周有所改善;两组之间唯一可见的显著差异是在治疗结束时,提萨苏利泥敷组更有利(p=0.009)。提萨苏利和科洛普泥敷都对膝骨关节炎患者的膝关节疼痛、身体功能和生活质量有良好的影响。我们的结果证明了提萨苏利泥敷的非劣效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73ef/7266795/4edea93824f4/484_2019_1764_Fig1_HTML.jpg

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