Effect of Acupuncture or Moxibustion at Acupoints Weizhong (BL40) and Chize (LU5) on the Change in Lumbar Temperature in Healthy People

the investigators will design a 2×2 randomized controlled trial, divided into four groups according to different acupoints (Weizhong and Chize) and different interventions (acupuncture and moxibustion). Patients will be randomized to one of the four treatment arms: (1) AW group: acupuncture at Weizhong point, (2) AC group: acupuncture at Chize point, (3) MW group: moxibustion at Weizhong point, (4) MC group: moxibustion at Chize point. All groups receive the intervention for 30 minutes. This trial will be carried out in the Third Affiliated Hospital of Zhejiang Chinese Medical University. the investigators will measure the average temperature difference of the lumbar region, the average temperature difference of the first lateral line of the Bladder meridian, and the average temperature difference of the second lateral line of the bladder meridian at different time nodes (Pre-intervention, 0, 5, 10, 15, 20, 25, 30 minutes) in all groups.

the investigators used the change of the average temperature (ΔT) in lumbar region from baseline to 30 minutes after intervention as the main effect indicator to estimate the sample size. Sample size calculations are performed to determine the number of participants needed to detect effect sizes. According to previously published results[7, 8] and our preliminary data, the mean and SD of the average temperature difference are μ1 = 0.84 μ2 = 0.34, μ3 = 0.70, and μ4 = 0.20 in the Acu-BL40 group, Acu-LU5 group, Mox-BL40 group and Mox-LU5 group, respectively, with SD σ = 0.26. k represents the number of groups and equals 4 in this trial. Type I error of 5% (α = 0.05) and 80% power (β = 0.20). Estimating a 20% dropout rate during the study, a minimum of 140 total participants is needed to reach the target of 35 participants per group. The investigators will undertake subgroup analysis in BL40 group, according to the pilot study performed previously, although there are about 40% participants can fell the warmth at lumbar region, the ΔT in lumbar region is more significant than others, therefore, the investigators decide not to expand the sample size.

the investigators will recruit 140 eligible participants from Zhejiang Chinese Medical University with age above 18 years. The eligible patients must meet the following inclusion criteria as well as the exclusion criteria. Anticipants will be recruited through an advertisement at the university, and through flyers at several locations of the internet. Interested participants can contact the project leader (PL) through their therapist, by phone or mail. If an applicant meets the study criteria, he or she will be invited to the research.

Temperature detection and measurement Thermal images were obtained using the FLIR E53 camera (FLIR Systems, Inc., Wilsonville, OR, USA). This thermal camera has an infrared resolution of 240×180 pixels and a visible light resolution of 640×480 pixels. The FLIR E53 camera has a scene range temperature range of -20 °C to 650 °C and can detect temperature differences as small as 0.04 °C.

Make the FLIR E53 camera perpendicular to the observing area (pre-marked area and acupoints), from 80 cm. Each participant will be evaluated in a room with a constant temperature of 26°C and 40%-60% humidity. The first photograph will be taken after the participants have rested for 20 min, other photographs will be sequentially taken at 0, 5, 10, 15, 20, 25 and 30 minutes once acupuncture/moxibustion has started and right after the intervention has ended. Heat lamps and other extraneous heat sources are switched off to prevent incorrect measurements.