Effect of acupuncture or moxibustion at Acupoints Weizhong (BL40) or Chize (LU5) on the change in lumbar temperature in healthy adults: A study protocol for a randomized controlled trial with a 2 × 2 factorial design

Background: Low back pain is a common complaint among adults, and moxibustion and acupuncture are commonly used treatments. In traditional theory, Weizhong (BL40) is a popular acupoint, as supported by the saying “Yao Bei Wei Zhong Qiu.” However, the difference in efficacy between acupuncture and moxibustion remains unclear. Therefore, this trial will compare the thermal effects of acupuncture and moxibustion at BL40 and Chize point (LU5) in healthy adults to provide more objective evidence regarding the relationship between the lumbar and BL40. Method/Design: The trial will use a two-by-two factorial design, randomly assigning 140 participants to four groups (acupuncture at Weizhong (BL40), acupuncture at Chize (LU5), moxibustion at Weizhong (BL40), and moxibustion at Chize (LU5)) at a ratio of 1:1:1:1. Each group will undergo a 30-minute intervention, with the primary outcome being mean temperature in the lumbar region at the last minute of the intervention period. Secondary outcomes include maximum lumbar temperature in the lumbar region at the last minute of the intervention, average lumbar temperature and average bladder meridian temperature at specific time points during and after the intervention, and scores on the warming sensation questionnaire. Data will be analyzed on an intention-to-treat basis. Discussion: This study will be the first to compare the thermal effect difference in the lumbar area between acupuncture and moxibustion in healthy individuals. The findings of this study will provide new insights for the "Yao Bei Wei Zhong Qiu" theory of traditional Chinese medicine. Trial registration: ClinicalTrials.gov, Trial number: NCT05665426. Registered on 26 December 2022.