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. 2019 Feb 13;20(1):126.
doi: 10.1186/s13063-019-3233-7.

The cerebral mechanism of acupuncture for treating knee osteoarthritis: study protocol for a randomized controlled trial

Jing Guo  1 , Yang Chen  1 , Zhengjie Li  1 , Shirui Cheng  1 , Chenjian Tang  1 , Xiaohui Dong  1 , Wenhua He  1 , Yong Huang  2 , Bao Yin  2 , Yu Sheng  1 , Jun Zhou  1 , Aijia Li  1 , Fang Zeng  1 , Lei Lan  3 , Fanrong Liang  4
Affiliations

The cerebral mechanism of acupuncture for treating knee osteoarthritis: study protocol for a randomized controlled trial

Jing Guo et al. Trials. .

Abstract

Background: Acupuncture is safe and effective for reducing the symptoms of knee osteoarthritis (KOA), but the underlying mechanisms of acupuncture for treating KOA are not fully understood.

Methods/design: In total, 108 participants diagnosed with KOA will be recruited. They will be blinded to group assignment and randomized to either verum acupuncture, sham acupuncture or waiting-list groups with 36 patients in each group. Each patient in the acupuncture group will receive five treatments per week for 2 weeks. This study will focus on detecting the cerebral functional connectivity changes elicited by acupuncture treatment. The Visual Analog Scale and the short form of the McGill Pain Questionnaire, the Western Ontario and McMaster Universities Osteoarthritis Index, the Attention Test Scale, the Pain Assessment of Sphygmomanometer and the 12-Item Short Form Health Survey will be used to evaluate the symptoms and quality of life improvement at the baseline and the end of treatment. The Self-rating Anxiety Scale and the Self-rating Depression Scale will be used at the baseline and the end of treatment to investigate the influence of emotional state on brain activity and clinical variable. To ensure the consistency of acupuncture manipulation, the deqi scale will be performed after each acupuncture treatment. During the procedure of outcome evaluation and data analysis, the evaluators and statisticians will be blinded to the group allocation. The repeated measures analysis of variance (3 groups × 2 time points ANOVA) will be employed to analyze numerical variables of the clinical and neuroimaging data generated in the study, then the t test will be used in the post-hoc analysis.

Discussion: The results of this randomized, sham- and waiting-list-controlled functional magnetic resonance imaging (fMRI) study will help to investigate the influence of verum acupuncture treatment on the brain activities of patients with KOA, which might provide evidence for the clinical application of verum acupuncture for KOA management.

Trial registration: Chinese Clinical Trial Registry, ID: ChiCT-IOR-17012364 . Registered on 14 August 2017.

Keywords: Acupuncture; Central mechanism; Functional magnetic resonance imaging; Knee pain.

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Conflict of interest statement

Ethics approval and consent to participate

This study will be performed according to the guidance and principles of the Declaration of Helsinki. The protocol has been approved by the supervision of the Sichuan Regional Ethics Review Committee on traditional Chinese medicine (ethical approval number 2016KL-017) and has been registered in the Chinese Clinical Trial Registry (ID: ChiCT-IOR-17012364). Only patients who have signed the informed consent form will be included.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the trial. The present study is a randomized controlled neuroimaging trial. One hundred and eight knee osteoarthritis (KOA) patients will be included and randomized equally to one of three groups: a verum acupuncture group, a sham acupuncture group and a waiting-list group. For the 36 patients in each group, this trial will include a 2-week baseline period and a 2-week treatment period. During the 2-week treatment, patients in the two acupuncture groups will receive 10 sessions of puncturing treatments, while the waiting-list group will not receive acupuncture. Both the outcome assessments and functional magnetic resonance imaging (fMRI) scan will be performed at two time points: baseline and end of acupuncture treatments. The central mechanism of verum acupuncture in the treatment of KOA will be analyzed after data collection
Fig. 2
Fig. 2
Study schedule for data collection. The informed consent and examination will be conducted after recruitment. Then, matched KOA patients will be randomized into three groups, only two acupuncture groups will receive treatment. Both clinical outcomes and functional magnetic resonance imaging (fMRI) scans will be performed at two time points including: the baseline and the end of acupuncture treatments. Adverse events will be recorded in the case report form at any time during the study. VAS Visual Analogue Score, MPQ McGill Pain Questionnaire, WOMAC Western Ontario and McMaster University Osteoarthritis Index, ATS Attention Test Scale, PAS Pain Assessment of Sphygmomanometer, SAS Self-Rating Anxiety Scale, SDS Self-Rating Depression Scale, SF-12 Short Form 12 Health Survey
Fig. 3
Fig. 3
Locations of acupoints: SP9 (yinlingquan), on the medial side of the shank, at the depression posterior and inferior to the medial condyle of the tibia. GB34 (yanglingquan), on the lateral side of the lower leg, in the depression anterior and inferior to the head of the fibula. EX-LE04 (neixiyan), in the depression located on the medial side of the patellar ligament. EX-LE5 (waixiiyan), in the depression located on the external side of the patellar ligament
Fig. 4
Fig. 4
Locations of sham acupoints: NP-1 (sham acupoint 1), 2–3 cm behind GB34. NP-2 (sham acupoint 2), 2–3 cm behind SP9
Fig. 5
Fig. 5
Locations of sham acupoints: NP-3 (sham acupoint 3), 4 cun above the base of the patella and the midpoint between the Spleen Meridian and Stomach Meridian. NP-4 (sham acupoint 4), 4 cun above the base of the patella and the midpoint between the Gallbladder Meridian and Stomach Meridian
See this image and copyright information in PMC

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