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Randomized Controlled Trial
. 2018 Dec 12;19(1):680.
doi: 10.1186/s13063-018-3049-x.

Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial

Hyun-Jong Lee  1 , Byung Il Choi  2 , Seungah Jun  1 , Mu Seob Park  1 , Se Jung Oh  1 , Jung Hee Lee  1 , Han Mi Gong  1 , Jae Soo Kim  1 , Young Joon Lee  3 , So-Young Jung  4 , Chang Hyun Han  5
Affiliations
Randomized Controlled Trial

Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial

Hyun-Jong Lee et al. Trials. .

Abstract

Background: We investigated the efficacy and safety of thread-embedding acupuncture (TEA) for chronic low back pain (LBP) in a randomized controlled pilot trial with the aim of laying the foundation for a large-scale randomized controlled trial on this topic.

Methods: Forty participants were recruited for this two-arm, assessor-blinded randomized controlled pilot trial. The participants were randomly allocated to a TEA group (experimental group) or an acupuncture group (control group). The TEA group received TEA once every 2 weeks for 8 weeks (four sessions in total), while the acupuncture group received acupuncture twice per week for 8 weeks (16 sessions in total). The primary outcome was the visual analog scale (VAS) score for pain and the secondary outcomes were short-form McGill Pain Questionnaire (SF-MPQ) and Oswestry Disability Index (ODI) scores. Assessments were performed at screening and at 2, 4, 6, 8, and 10 weeks after treatment initiation (the 10-week assessment was conducted at 2 weeks after treatment cessation).

Results: Of the 40 participants, 36 completed the study and four dropped out. Both the TEA group and the acupuncture group showed significant improvements in VAS, SF-MPQ, and ODI scores in a time-dependent manner. Furthermore, with regard to ODI, a significant interaction between group and time was observed, with the two groups exhibiting a different pattern of change at 8 weeks according to contrast analysis with Bonferroni's correction. No serious adverse event occurred, and hematological and biochemical test findings were within normal limits.

Conclusion: This pilot study has provided basic data for a larger clinical trial to demonstrate the efficacy and safety of TEA for chronic LBP.

Trial registration: Clinical Research Information Service of the Korea National Institute of Health, ID: KCT0001819 . Registered on 15 February 2016.

Keywords: Acupuncture; Chronic low back pain; Thread-embedding acupuncture.

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Conflict of interest statement

Authors’ information

HJL, SAJ, MSP, SJO, JHL, HMG, JSK: Department of Acupuncture and Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu 42158, Republic of Korea.

BIC: Choibyungil 3S Korean Medical Clinic, Ulsan 44726, Republic of Korea.

YJL: Department of Preventive Medicine, College of Korean Medicine, Daegu Haany University, Gyeongsan 38610, Republic of Korea.

SYJ, CHH: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.

Ethics approval and consent to participate

The study protocol was approved by the IRB of Daegu Oriental Hospital of Daegu Haany University, Daegu, Republic of Korea (IRB approval number DHUMC-D-15015-ANS-01).

Consent for publication

The study findings will be published in open-access journals and presented at national and international conferences.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart for our randomized controlled pilot trial on the efficacy and safety of thread-embedding acupuncture for chronic low back pain
Fig. 2
Fig. 2
Parts of a thread-embedding acupuncture device
Fig. 3
Fig. 3
Treatment sites for thread-embedding acupuncture in the dorsal area of the human body
Fig. 4
Fig. 4
Treatment sites for thread-embedding acupuncture in the abdominal area of the human body
Fig. 5
Fig. 5
Changes in VAS, SF-MPQ, and ODI scores in TEA and acupuncture groups. * p < 0.05: statistically significant difference according to repeated-measures analysis of variance (ANOVA) by contrast analysis with Bonferroni’s correction on time. † p < 0.05: statistically significant difference according to repeated-measures analysis of variance (ANOVA) by contrast analysis with Bonferroni’s correction on time and group interaction. MPQ short-form McGill Pain, ODI Oswestry Disability Index, PPI Present Pain Intensity scale, TEA thread-embedding acupuncture, VAS visual analog scale
See this image and copyright information in PMC

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