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聚二氧六环酮埋线针灸与物理治疗相比治疗非特异性慢性颈痛患者的有效性和安全性:一项评估者盲法、随机、对照临床试验

Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture Compared to Physical Therapy in the Treatment of Patients with Non-Specific Chronic Neck Pain: An Assessor-Blinded, Randomized, Controlled, Clinical Trial.

作者信息

Kim Jae Ik, Han Chang-Hyun, Jeon Ju Hyun, Kim Jin Youp, Kwon Ojin, Jung So-Young, Lee Jun-Hwan, Yang Changsop, Kim Eunseok, Kim Young Il

机构信息

Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.

Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.

出版信息

J Pain Res. 2021 Jan 28;14:201-211. doi: 10.2147/JPR.S276941. eCollection 2021.

DOI:10.2147/JPR.S276941
PMID:33536781
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7850897/
Abstract

BACKGROUND

Thread embedding acupuncture (TEA) has recently been used as a conservative treatment method for non-specific chronic neck pain (CNP). The objective of this study was to evaluate the effectiveness and safety of TEA compared to physical therapy (PT) for treating patients with CNP.

METHODS

A total of 128 patients diagnosed with CNP were randomly assigned to a TEA group and a PT group at a 1:1 ratio. The TEA group received four sessions of TEA, while the PT group received eight sessions of PT over 4 weeks. Outcomes were assessed using Neck Pain and Disability Scale (NPDS), clinically important difference (CID), cervical spinal angle, Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Patient Global Impression of Change (PGIC), and EuroQol Five-Dimension (EQ-5D) at baseline and 5, 9, and 13 weeks.

RESULTS

The TEA group showed significant improvement in NPDS compared to the PT group at 5, 9, and 13 weeks. Proportions of patients with decreased NPDS scores of more than 11.5 points (minimal CID) were significantly higher in the TEA group at 5, 9, and 13 weeks. There were significant differences between the two groups at 5, 9, and 13 weeks for BDI-II, and at 5 and 9 weeks for BAI. For EQ-5D, the TEA group showed significant improvement at 5, 9, and 13 weeks. There was no significant difference in cervical spinal angle between the two groups. For PGIC, better improvement was observed at 9 and 13 weeks in the TEA group. Adverse events associated with interventions were mostly temporary and mild.

CONCLUSION

For patients with CNP, TEA treatment was found to be more effective than PT treatment for improving their pain and dysfunction, quality of life, and psychological distress. Despite some post-treatment discomfort, TEA treatment can be considered as a useful treatment method for patients with CNP.

TRIAL REGISTRATION

This trial has been registered 5 April 2019 in Clinical Research Information Service of South Korea (CRIS- KCT0003720).

摘要

背景

埋线针灸(TEA)最近已被用作非特异性慢性颈痛(CNP)的保守治疗方法。本研究的目的是评估与物理治疗(PT)相比,TEA治疗CNP患者的有效性和安全性。

方法

总共128例被诊断为CNP的患者按1:1的比例随机分为TEA组和PT组。TEA组接受4次TEA治疗,而PT组在4周内接受8次PT治疗。在基线以及第5、9和13周时,使用颈痛和残疾量表(NPDS)、临床重要差异(CID)、颈椎角度、贝克抑郁量表第二版(BDI-II)、贝克焦虑量表(BAI)、患者总体改善印象(PGIC)和欧洲五维健康量表(EQ-5D)评估结果。

结果

在第5、9和13周时,TEA组与PT组相比,NPDS有显著改善。在第5、9和13周时,NPDS评分降低超过11.5分(最小CID)的患者比例在TEA组中显著更高。两组在第5、9和13周时BDI-II存在显著差异,在第5和9周时BAI存在显著差异。对于EQ-5D,TEA组在第5、9和13周时有显著改善。两组之间颈椎角度无显著差异。对于PGIC,TEA组在第9和13周时有更好的改善。与干预相关的不良事件大多是暂时的且轻微。

结论

对于CNP患者,发现TEA治疗在改善疼痛和功能障碍、生活质量以及心理困扰方面比PT治疗更有效。尽管治疗后有一些不适,但TEA治疗可被认为是CNP患者的一种有用治疗方法。

试验注册

本试验于2019年4月5日在韩国临床研究信息服务中心(CRIS-KCT0003720)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/b9d8109a135a/JPR-14-201-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/1fc9192aa7f5/JPR-14-201-g0001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/edc790c4bbbe/JPR-14-201-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/b9d8109a135a/JPR-14-201-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/1fc9192aa7f5/JPR-14-201-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/1f8942a553c3/JPR-14-201-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/6f38cf3e3e4f/JPR-14-201-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/edc790c4bbbe/JPR-14-201-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84d2/7850897/b9d8109a135a/JPR-14-201-g0005.jpg

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