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. 2018 Sep 10;19(1):484.
doi: 10.1186/s13063-018-2864-4.

Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial

Bonhyuk Goo  1 , Dek-Woo Ryoo  1 , Eun-Jung Kim  2 , Dongwoo Nam  3 , Hyun-Jong Lee  4 , Jae-Soo Kim  4 , Yeon-Cheol Park  5 , Yong-Hyeon Baek  5 , Byung-Kwan Seo  6
Affiliations

Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial

Bonhyuk Goo et al. Trials. .

Abstract

Background: A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embedding acupuncture (TEA) is effective in the treatment of LHIVD. However, these studies were of low quality and there is therefore little clinical evidence for the effectiveness of TEA in this regard. The aim of the present study is to establish the clinical evidence regarding the efficacy and safety of TEA in the treatment of pain, function, and quality of life in patients with LHIVD. The study uses a rigorously designed, full-scale, randomized clinical trial (RCT) protocol.

Method/design: This is a multicenter, randomized, patient-assessor blinded, sham-controlled trial with two parallel arms. Seventy patients with LHIVD who have lower back pain more severe than 40 mm on the 100-mm visual analogue scale (VAS), and who are aged 19-70 years, will be recruited and randomly allocated to a TEA group and sham TEA (STEA) group. Both groups will receive treatment on 23 predefined acupoints once a week for eight weeks; needles with the thread removed will be used in the STEA group, while normal TEA will be employed in the TEA group. Changes in the 100-mm VAS for lower back pain after eight weeks will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry Disability Index, Roland-Morris disability questionnaire, EuroQol 5 Dimensions 5 Levels, and global perceived effect will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4, 8, 12, and 16 weeks after screening.

Discussion: The results of this trial will help to establish the clinical evidence regarding TEA in the treatment of patients with LHIVD.

Trial registration: ClinicalTrials.gov, NCT03236753 . Registered on August 2, 2017. Clinical Research Information Service of the Republic of Korea, KCT0002439 . Registered on August 1, 2017.

Keywords: Lower back pain; Lumbar disc herniation; Lumbar herniated intervertebral disc; Radiculopathy; Thread-embedding acupuncture.

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Conflict of interest statement

Ethics approval and consent to participate

The protocol of this study has been approved by the IRB of four respective institutions (reference number: KHUHGD, KHNMCOH 2016-09-006; KHUMC, 161216-HR-006; DUBOH, 2016–0012; DKMHDHU, DHUMC-D16015-PRO-02) and the informed consent form is to be completed voluntarily before screening.

Consent for publication

Not applicable.

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
Study flowchart
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure. TEA thread-embedding acupuncture, STEA sham thread-embedding acupuncture, VAS visual analogue scale, ODI Oswestry Disability Index, RMDQ Roland-Morris disability questionnaire, EQ-5D-5 L EuroQol 5 Dimensions 5 Levels, GPE global perceived effect
See this image and copyright information in PMC

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