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

Abstract

Abstract Background Low back pain is a common complaint among adults, and moxibustion and acupuncture are commonly used treatments. According to traditional theory, acupoint Weizhong is a popular choice, with the saying “Yao Bei Wei Zhong Qiu.” However, the difference in efficacy between acupuncture and moxibustion remains unclear. Therefore, this trial compared the thermal effects of acupuncture and moxibustion at Weizhong and Chize point in healthy adults to provide more objective evidence of the lumbar-Weizhong relationship.Method/design The trial will use a two-by-two factorial design, randomly assigning 140 participants to four groups (acupuncture at Weizhong, acupuncture at Chize, moxibustion at Weizhong, and moxibustion at Chize) in a ratio of 1:1:1:1. Each group will receive a 30-minute intervention, with the primary outcome being the change in average temperature in the lumbar area from baseline to 30 minutes post-intervention. Secondary outcomes include changes in maximum lumbar temperature, changes in average lumbar temperature at various time points during and post-intervention, changes in average temperature in the Bladder meridian, and the warming sensation questionnaire. The results of the warming sensation questionnaire will be utilized for subgroup stratification in the BL40 group. Additionally, an intention-to-treat analysis will be conducted regardless of adherence.Discussion This study will be the first one to compare the thermal effect difference at 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.