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. 2022 Jul 6:10:930830.
doi: 10.3389/fpubh.2022.930830. eCollection 2022.

The Effect of Thunder-Fire Moxibustion on Lumbar Disc Herniation: Study Protocol for a Randomized Controlled Trial

Jiale Zhang  1 , Xu Zhai  2 , Xue Wang  3 , Liuqing Wang  4 , Hongxuan Tong  1 , Tiancai Xian  5 , Lexuan Shao  2
Affiliations

The Effect of Thunder-Fire Moxibustion on Lumbar Disc Herniation: Study Protocol for a Randomized Controlled Trial

Jiale Zhang et al. Front Public Health. .

Abstract

Background: Lumbar disc herniation (LDH) is a common disease seen in orthopedics; it is caused by nucleus pulposus herniation. Its clinical manifestations are low back pain, radiating pain of the lower limbs, and cauda equina symptoms that seriously affect patients' quality of life. At present, oral analgesics are commonly used in the treatment of LDH; but they can produce gastrointestinal reactions and other side effects. Thunder-fire moxibustion is a method that is widely used in China to treat pain syndromes. This study aimed to design a randomized controlled trial to explore the effectiveness and safety of thunder-fire moxibustion in the treatment of lumbar disc herniation.

Methods: Ninety patients will be enrolled and randomly divided into one of two groups: the thunder-fire moxibustion group and the acetaminophen group. The thunder-fire moxibustion group will be treated with moxa sticks at BL25, GV3, BL23, and GV4; and after 15 min of local whirling moxibustion, the contralateral acupoints will be treated with moxibustion for 15 min. The study period will include two 10-day courses of treatment, for a total study duration of 20 days. The acetaminophen group participants will take one acetaminophen sustained-release tablet twice a day for the duration of the study period. In contrast, the thunder-fire moxibustion group participants will be treated with thunder-fire moxibustion every other day for 30 min. The primary outcome will be the Japanese Orthopedic Association (JOA) score. Visual analog scale (VAS) and Oswestry Disability Index (ODI) will be used as the secondary outcome measures. Adverse events (AEs) will also be recorded. Assessments will be conducted at baseline, the end of the first and second courses of treatment.

Discussion: This study will determine whether thunder-fire moxibustion is more effective and safer than acetaminophen in the treatment of patients with LDH.

Trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR2000036079.

Keywords: complementary medicine; lumbar disc herniation; moxibustion; protocol; randomized controlled trial.

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Conflict of interest statement

TX was employed by Genius Tianzhiyuan Group Co., Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of the trial. A total of 90 participants will be randomized to the two groups. The study period will consist of the baseline, end of the 10-day intervention, and 20-day intervention.
Figure 2
Figure 2
Location of acupoints. BL25 (Dachangshu); under the spinous process of the fourth lumbar spine, with a side opening of 5 cm. GV3 (Yaoyangguan); on the posterior midline, under the spinous process of the fourth lumbar spine. BL23 (Shenshu); under the spinous process of the second lumbar spine, with a side opening of 5 cm. GV4 (Mingmen); on the posterior midline, under the spinous process of the second lumbar spine.
Figure 3
Figure 3
Study schedule. VAS, visual analog scale; ODI, oswestry disability index.
See this image and copyright information in PMC

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