Effect of Acupuncture on the Cognitive Control Network of Patients with Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

Shuai Yin; Zhen-Hua Zhang; Yi-Niu Chang; Jin Huang; Ming-Li Wu; Qi Li; Jin-Qi Qiu; Xiao-Dong Feng; Nan Wu

doi:10.2147/JPR.S356044

Effect of Acupuncture on the Cognitive Control Network of Patients with Knee Osteoarthritis: Study Protocol for a Randomized Controlled Trial

J Pain Res. 2022 May 18:15:1443-1455. doi: 10.2147/JPR.S356044. eCollection 2022.

Authors

Shuai Yin^#¹, Zhen-Hua Zhang^#¹, Yi-Niu Chang^#², Jin Huang², Ming-Li Wu¹, Qi Li¹, Jin-Qi Qiu¹, Xiao-Dong Feng^{1

2}, Nan Wu²

Affiliations

¹ Rehabilitation Center, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450000, People's Republic of China.
² School of Rehabilitation Medicine, Henan University of Chinese Medicine, Zhengzhou, Henan, 450046, People's Republic of China.

^# Contributed equally.

Abstract

Purpose: Abnormal central nervous system function is the key central pathological factor leading to chronic pain in patients with knee osteoarthritis (KOA). Acupuncture can effectively relieve the pain of KOA patients. However, the central nervous mechanism of acupuncture treating KOA is not fully understood. This trial will use functional magnetic resonance imaging (fMRI) analysis techniques to investigate the potential central nervous mechanism of acupuncture treatment of KOA.

Materials and methods: A total of 108 patients will be randomized (in a 1:1:1 ratio) into three groups, this trial will include 4-week treatment, patients in groups A and B will receive 20 acupuncture and sham acupuncture sessions, respectively, patients in group C will not receive any intervention, and all patients will receive fMRI scans before and after the intervention. The Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC) will be the primary clinical outcome. Then, we will explore the functional changes of the cognitive control network (CCN) in the brains of KOA patients through whole brain functional connectivity (FC) analysis and seed-based functional connectivity (sFC) analysis. Pearson correlation coefficient will be used to analyze the relationship between the improved value of the clinical correlation scale and the change of fMRI data.

Discussion: This trial will analyze the efficacy of verum acupuncture, sham acupuncture and the waiting-list for KOA and explore the activity of the CCN in three groups of patients by fMRI, so as to reveal the central nervous mechanisms of acupuncture in the treatment of KOA.

Study registration: This study is approved by the Ethics Committee of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine (No: 2019HL-133-01) and registered in the Chinese Clinical Trial Registry, ChiCTR2000038554.

Keywords: acupuncture; cognitive control network; knee osteoarthritis; randomized controlled trial.

Grants and funding

This study is supported by the Science and Technology Department of Henan Province (182102310311, 192102310162), Special Project of Scientific Research on Traditional Chinese Medicine in Henan Province (grant number 2017JDZX030, 2018JDZX035, 2018JDZX115, 2019JDZX2001), training Program of leading talents in Clinical disciplines of traditional Chinese Medicine in Henan Province (2100202). The sponsors have no role in the design of the trial; collection, management, analysis, and interpretation of data; writing of the report, or the decision to submit the report for publication.