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慢性腰痛中使用非药物贴膏:一项随机对照试验。

Use of a non-medicated plaster in chronic lumbar back pain: a randomized controlled trial.

机构信息

AOUI Verona.

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出版信息

Acta Biomed. 2022 Aug 31;93(4):e2022260. doi: 10.23750/abm.v93i4.12931.

Abstract

BACKGROUND

The latest technology on far infrared radiations reflects the radiations emitted by the human body and induces an antalgic and anti-inflammatory effect without active ingredients. Our primary aim was to assess pain level modifications throughout the treatment period with two different types of patches, compared to a placebo. As secondary aims, we focused on addressing patients' quality of life and range of motion changes with each patch.

METHODS

We assessed 54 patients with chronic lumbar back pain treated with FIT Therapy (far infrared technology) patch. Three different types of FIT Therapy patches (F4, F3, and placebo) were used according to the different power of action and patients allocated in a randomized fashion into the 3 arms of the study. Every single patient was assessed during the study using the VAS pain scale, the Roland Morris Disability Questionnaire for quality of life, and ROM for a total of 14 days.

RESULTS

Only the F4 patch group significantly reduced pain level at T14 compared to the placebo group (p<0.05). Meanwhile, F3 showed only a non-significant decrease compared to placebo (p=0.254). In terms of lifestyle improvements, both F3 and F4 recorded a decrease on the RMDQ of 4 and 6 points, respectively.

CONCLUSIONS

Currently, we still need further studies with longer follow-up to consider the FIT Therapy patches F4 a valid alternative as a "non-medicated pain relief", but it proved to have a role in alleviating painful symptoms and improving function in chronic lumbar back pain without adverse events.

摘要

背景

最新的远红外辐射技术反映了人体发出的辐射,并在没有活性成分的情况下产生镇痛和抗炎作用。我们的主要目的是评估两种不同类型的贴片在治疗期间对疼痛程度的改变,与安慰剂相比。作为次要目标,我们专注于解决每个贴片对患者生活质量和活动范围的改变。

方法

我们评估了 54 名患有慢性腰痛的患者,他们接受了 FIT 治疗(远红外技术)贴片的治疗。根据不同的作用强度,使用了三种不同类型的 FIT 治疗贴片(F4、F3 和安慰剂),并根据患者的情况将其随机分配到研究的 3 个组中。每位患者在研究期间使用 VAS 疼痛量表、Roland Morris 残疾问卷评估生活质量和 ROM 进行评估,共 14 天。

结果

只有 F4 贴片组在 T14 时与安慰剂组相比显著降低了疼痛水平(p<0.05)。而 F3 与安慰剂相比仅显示出非显著性下降(p=0.254)。在生活方式改善方面,F3 和 F4 组分别记录到 RMDQ 评分下降了 4 分和 6 分。

结论

目前,我们仍需要进行更长时间随访的进一步研究,以考虑将 FIT 治疗贴片 F4 作为一种“非药物止痛”的有效替代方法,但它已被证明在缓解慢性腰痛的疼痛症状和改善功能方面具有作用,且无不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/694f/9534234/a3cedf3d5383/ACTA-93-260-g001.jpg

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