Infrared Thermography-based Study of the Warming Effect Difference at Waist

NCT05665426 | Completed Results

• 1 other identifier: 20221101091119441
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is a common clinical condition, with up to 84% of adults experiencing varying degrees of low back pain. The most common form of low back pain is non-specific low back pain, which is often treated symptomatically in medicine due to its lack of etiology, which has many side effects. In contrast, acupuncture has the advantage of being practical and free of side effects. The use of acupuncture points in the lumbar region has a long history of application, as early as the《Huangdi Neijing》thousands of years ago. In the Ming Dynasty, there were summaries of the experience of " Yaobei Weizhong Qiu" (Which means the Weizhong point is closely associated with the waist). Weizhong point's efficacy in lumbar diseases (e.g., lumbar disc herniation, lumbago, sciatica, etc.) is still confirmed. One of the mechanisms is closely related to the improvement of microcirculation, which can be visualized by observing changes in infrared thermal parameters. Acupuncture and moxibustion are the most common therapies at Weizhong point, but there is a lack of research on the differences in efficacy between the two. Therefore, this study aims to collect the temperature parameters of the lumbar region in healthy subjects after acupuncture/moxibustion to estimate the difference in the therapeutic effect on the lumbar region, which can help to reveal the effect differences between acupuncture and moxibustion. As well as to provide scientific evidence to enrich the connotation of the classical theory " Yaobei Weizhong Qiu." the investigators will test the following hypotheses:

1. 1.Hypotheses for main effects of different point selection(LU 5 and BL 40)： H1: There is a significant difference in average temperature change at the waist at 30 minutes between the Weizhong(BL 40) group and the Chize(LU 5) group.
2. 2.Hypotheses for the main effects of different interventions (acupuncture and moxibustion) H1: There is a significant difference in average temperature change at the waist at 30 minutes between the acupuncture group and the moxibustion group.

Conditions

Health

Keywords

acupuncture; moxibustion; Weizhong; waist

Outcome Measures

Primary Outcomes (1)

• ΔT at the Waist Between 30 Minutes and the Baseline.

  The temperature difference (ΔT)at the waist between 30 minutes and the baseline.

  30 minutes after the intervention has begin

Secondary Outcomes (4)

• δT of The Maximum Temperature in the Designated Area of the Waist After 30 Minutes.

  30 minutes after the intervention has begin

• The Temperature at the Waist Between 5 ,10 ,15 ,20 ,25, 30 Minutes and Baseline.

  5 minutes,10 minutes,15 minutes,20 minutes,25 minutes , 30 minutes after the intervention has begin

• ΔT at the Governor Vessel Between 30 Minutes and Baseline

  30 minutes after the intervention has begin

• Number of Participants Reporting a Sensation of Warmth in the Lower Back

  Immediately after completion of the intervention session (within 5 minutes of needle withdrawal).

Study Arms (4)

AW group

OTHER

(1) AW group: acupuncture at Weizhong point,

Other: acupuncture

AC group

OTHER

(2) AC group: acupuncture at Chize point,

Other: acupuncture

MW group

OTHER

(3) MW group: moxibustion at Weizhong point,

Other: moxibustion

MC group

OTHER

(4) MC group: moxibustion at Chize point.

Other: moxibustion

Interventions

acupuncture OTHER

Patients allocated to the acupuncture group will be punctured at the pre-specified acupoints. According to the theory of traditional Chinese medicine and clinical experience, we will use the Bilateral Weizhong point (BL 40). Because of the similar anatomy, the Chize point (LU 5) was chosen as a control. Sterile disposable stainless steel acupuncture needles (length: 40 mm, diameter: 0.25 mm; Hwato, Suzhou, China) will be used.

AC group; AW group

moxibustion OTHER

Moxibustion Participants in the moxibustion group will receive moxibustion treatment via portable Moxibustion (Aikeshu, Bozhou, China); the moxibustion is composed of The inner tube (containing the moxa pillar) and the outer tube. To use, pull out the inner tube and light the moxa pillar, then insert the outer tube and fix the moxibustion on the acupuncture points. Two Moxibustion devices will be sequentially applied at two acupoints Weizhong (BL 40) and Chize (LU 5), for 30 minutes.

MC group; MW group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-60 (either sex);
• with a BMI of 18.5-23.9 kg/m2;
• with no history of lower back pain;
• with normal range of lumbar mobility (including flexion from 75-90 degrees, extension of 30 degrees, lateral bending from 20-35 degrees, and unilateral rotation of 90 degrees);
• willing to participate in the trial and have signed the informed consent form.

You may not qualify if:

• participants with serious heart, liver, kidney, or hematological diseases;
• women in menses, pregnancy, or lactation;
• those unable to complete the imaging in prone position (about 40 minutes);
• those with cognitive impairments;
• those with a history of lower back trauma or whiplash within a week;
• those with skin diseases or skin lesions, sensory impairments, scarring, or neoplasms at the test site;
• those with metal allergies
• those who have participated in other clinical trials that may affect the results of the study within the last three weeks.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

the Ethics Board of The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (2)

• Zheng SY, Wang XY, Lin LN, Liu S, Huang XX, Liu YY, Yu XS, Pan W, Fang JQ, Liang Y. Lumbar temperature change after acupuncture or moxibustion at Weizhong (BL40) or Chize (LU5) in healthy adults: A randomized controlled trial. J Integr Med. 2025 Mar;23(2):145-151. doi: 10.1016/j.joim.2025.01.004. Epub 2025 Jan 16.

  PMID: 39863500 DERIVED

• Zheng S, Shen Q, Lyu Z, Tian S, Huang X, Liu Y, Yu X, Pan W, Nie N, Liang Y, Fang J. 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 x 2 factorial design. PLoS One. 2023 Oct 30;18(10):e0291536. doi: 10.1371/journal.pone.0291536. eCollection 2023.

  PMID: 37903112 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy; Moxibustion

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Siyi Zheng
• Organization: Zhejiang Chhinese Medicial University

zsy980714@gmail.com

+86159 9008 8547

Study Officials

• Yi Liang, PhD

  The Third Affiliated Hospital of Zhejiang Chinese Medicial University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The eligible patients will be given a sequential study number by research staff. Subsequently, their basic information will be entered into an internet-based and password-protected clinical research management system (ResMan Research Manager, supported by West China Hospital, Sichuan University, China), which will automatically generate a research code and randomly allocate participants to one of four groups (Acu-BL40 group, Acu-LU5 group, Mox-BL40 group or Mox-LU5 group) at a ratio of 1:1:1:1. Given the nature of the intervention, the participants and acupuncturists will be aware of the assignment. The research assistants responsible for data collection, biostatisticians and data analysis will be masked to study group allocation. Precise documentation of therapy will be recorded in the case report forms (CRFs) in an exclusive computer as well as on paper.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Model Details: 2×2 factorial design

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 27, 2022
• Study Start: April 14, 2023
• Primary Completion: June 25, 2023
• Study Completion: June 25, 2023
• Last Updated: October 1, 2025
• Results First Posted: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)