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. 2022 Jan 13;12(1):e050413.
doi: 10.1136/bmjopen-2021-050413.

Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial

Ning Sun  1 , Dong-Mei He  2 , Xiangyin Ye  1 , Lei Bin  2 , Yuanfang Zhou  1 , Xiaodong Deng  1 , Yuzhu Qu  1 , Zhengjie Li  1 , Shirui Cheng  1 , Shuai Shao  2 , Feng-Juan Zhao  3 , Tie-Huan Zhang  2 , Jing Cai  4 , Ruirui Sun  1 , Fan-Rong Liang  5
Affiliations

Immediate acupuncture with GB34 for biliary colic: protocol for a randomised controlled neuroimaging trial

Ning Sun et al. BMJ Open. .

Abstract

Introduction: As the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented with significance to lead to pain relief, the immediate analgesia of acupuncture for BC still needs to be verified, and the underlying mechanism has yet to be covered. Therefore, this trial aims first to verify the immediate pain-alleviation characteristic of acupuncture for BC, then to explore its influence on the peripheral sensitised acupoint and central brain activity.

Methods and analysis: This is a randomised controlled, paralleled clinical trial, with patients and outcome assessors blinded. Seventy-two patients with gallbladder stone disease presenting with BC will be randomised into a verum acupuncture group and the sham acupuncture group. Both groups will receive one session of immediate acupuncture treatment. Improvements in patients' BC will be evaluated by the Numeric Rating Scale, and the pain threshold of acupoints will also be detected before and after treatment. During treatment, brain neural activity will be monitored with functional near-infrared spectroscopy (fNIRS), and the needle sensation will be rated. Clinical and fNIRS data will be analysed, respectively, to validate the acupuncture effect, and correlation analysis will be conducted to investigate the relationship between pain relief and peripheral-cerebral functional changes.

Ethics and dissemination: This trial has been approved by the institutional review boards and ethics committees of the First Teaching Hospital of Chengdu University of Traditional Chinese Medicine, with the ethical approval identifier 2019 KL-029, and the institutional review boards and ethics committees of the First People's Hospital of Longquanyi District, with the ethical approval identifier AF-KY-2020071. The results of this trial will be disseminated through peer-reviewed publications and conference abstracts or posters.

Trial registration number: CTR2000034432.

Keywords: complementary medicine; hepatobiliary disease; pain management.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow chart of the study design. BC, biliary colic; fNIRS, functional near-infrared spectroscopy.
Figure 2
Figure 2
Standard protocol items. fNIRS, functional near-infrared spectroscopy; NRS, Numeric Rating Scale; SAS, Zung Self-rating Anxiety Scale; SDS, Zung Self-rating Depression Scale; SF-12, 12-item Short-form Health Survey.
Figure 3
Figure 3
Location of acupoint or non-acupoint in the trial.
Figure 4
Figure 4
Experimental paradigm.
Figure 5
Figure 5
Verum acupuncture and sham acupuncture.
See this image and copyright information in PMC

References

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