The Emotion Regulation of Acupuncture in Chronic Low Back Pain: A Clinical Neuroimaging Protocol

Abstract

Introduction

Acupuncture is effective for patients with chronic low back pain (CLBP), which can relieve pain intensity and regulate negative emotional states such as pain-related anxiety and depression. Previous studies mainly discuss the analgesic mechanism of acupuncture treatment of CLBP, but there are multiple dimensions to pain, including sensation, emotion and cognition. Therefore, this study aims to investigate the central mechanism of acupuncture for CLBP from the perspective of emotional regulation by functional magnetic resonance imaging (fMRI).

Methods and Analysis

A total of 72 patients with CLBP will be recruited in the study and randomly assigned to the verum acupuncture group or the sham acupuncture group. The trail will last for 18 weeks including a 2-week baseline, a 4-week treatment and a 12-week for follow-up period. The primary outcomes are the visual analog scale (VAS) and the Japanese Orthopaedic Association Scores (JOA) score. The secondary outcomes are the 12-item short form health survey (SF-12), the state trait anxiety inventory (STAI), the self-rating anxiety scale (SAS) and self-rating depression scale (SDS). The VAS, JOA, STAI SAS and SDS will be collected at baseline, week 2, week 4, and after follow-up. The SF-12 will be evaluated at baseline, week 2 and week 4. Functional magnetic resonance imaging (MRI) data will be collected at baseline and the end of treatment. Emotion-related brain regions will be chosen as regions of interest (ROIs). The gray matter volume (GMV), amplitude of low-frequency fluctuation (ALFF), regional homogeneity (ReHo), functional connectivity (FC), and large-scale functional brain network based on these ROIs will be analyzed within and between the two groups.

Discussion

This study will verify the emotional regulation of acupuncture and explore the mechanism of acupuncture for emotion regulation in patients with CLBP.

Trial Registration Number

https://www.chictr.org.cn/showproj.html?proj=195486, identifier: ChiCTR2300070557.

Keywords:

• acupuncture
• chronic low back pain
• emotion regulation
• functional magnetic resonance imaging

Trial Status

This clinical trial has been registered on the Chinese Clinical Trial Registry (https://www.chictr.org.cn) on April 17, 2023 (registration no. ChiCTR2300070557); protocol version no. 1.0). Patient recruitment was started on November 20, 2023.

Ethics Statement

This study was reviewed and approved by Review Boards and Medical Ethics Committee of Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (2023KL-120) and Ethics Committees of Chengdu Fifth People’s Hospital (Ethics 2023-003 (Section) −01).

Acknowledgments

Peng Lai and Shirui Cheng are co-first authors for this study. The authors thank Yucai Luo and Zilei Tian for study protocol design assistance.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Additional information

Funding

This study is financially supported by the National Natural Science Foundation of China (No. 82205288), China Postdoctoral Science Foundation (No. 2021MD703796), Sichuan Science and Technology Program (No. 2022NSFSC0856), Medical Technology Project of Health Commission of Sichuan Province (No. 21PJ110). The funders did not play any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.