Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial

Yu Heng Kwan, Warren Fong, Xiang Ling Ang, Chuen Seng Tan, Bee Choo Tai, Youyi Huang, Marcel Bilger, Jie Kie Phang, Hui Chin Tan, Jia Ven Lee, Limin Sun, Choy Tip Tan, Bao Qiang Dong, Hwee Ling Koh, Ying Ying Leung, Nai Lee Lui, Siaw Ing Yeo, Swee Cheng Ng, Kok Yong Fong, Julian Thumboo, Truls Østbye, Yu Heng Kwan, Warren Fong, Xiang Ling Ang, Chuen Seng Tan, Bee Choo Tai, Youyi Huang, Marcel Bilger, Jie Kie Phang, Hui Chin Tan, Jia Ven Lee, Limin Sun, Choy Tip Tan, Bao Qiang Dong, Hwee Ling Koh, Ying Ying Leung, Nai Lee Lui, Siaw Ing Yeo, Swee Cheng Ng, Kok Yong Fong, Julian Thumboo, Truls Østbye

Abstract

Background: Axial spondyloarthritis (AxSpA) is a chronic disease which results in fatigue, pain, and reduced quality of life (QoL). Traditional Chinese medicine (TCM), especially acupuncture, has shown promise in managing pain. Although a TCM collaborative model of care (TCMCMC) has been studied in cancer, there are no randomized controlled trials investigating TCM in AxSpA. Therefore, we will conduct a pragmatic trial to determine the clinical effectiveness, safety, and cost-effectiveness of TCMCMC for patients with AxSpA. We define TCMCMC as standard TCM history taking and physical examination, acupuncture, and TCM non-pharmacological advice and communications with rheumatologists in addition to usual rheumatologic care. The purpose of this paper is to describe the rationale for and methodology of this trial.

Methods/design: This pragmatic randomized controlled trial will recruit 160 patients who are diagnosed with AxSpA and have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Simple randomization to usual rheumatologic care or the intervention (TCMCMC) with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the TCMCMC arm. All participants will continue to receive usual rheumatologic care. The primary endpoint - spinal pain - will be evaluated at week 6. Secondary endpoints include clinical, quality of life, and economic outcome measures. Patients will be followed up for up to 52 weeks, and adverse events will be documented.

Discussion: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of a TCMCMC for patients with AxSpA.

Trial registration: ClinicalTrials.gov, NCT03420404 . Registered on 14 February 2018.

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by the SingHealth Centralized Institutional Review Board (Reference number: 2017/2088). Written informed consent is required for participation. Protocol amendments, adverse event reporting and annual review will be overseen by the CIRB.

Consent for publication

Consent to published de-identified information is included in the written informed consent process. However, no data is being published at this time.

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
SPIRIT figure for the schedule of enrollment, interventions, and assessments. Abbreviations: ASQoL Ankylosing Spondylitis Quality of Life, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, BAS-G Bath Ankylosing Spondylitis Global score, HAQ Health Assessment Questionnaire, QoL quality of life, SF-36 36-item Short Form Health Survey, SPIRIT Standard Protocol Items: Recommendations for Interventional Trials, TCM traditional Chinese medicine
Fig. 2
Fig. 2
Trial work plan. Follow-up will be performed at weeks 6, 12, 24, and 52 after the baseline visit. Pain score at week 6 is the primary outcome measure for this study. Outcome measures at week 52 are exploratory. The remaining outcome measures are the secondary outcomes of the study
Fig. 3
Fig. 3
The acupuncture points employed in this study. The main acupuncture points are Jiaji, Shenshu, Yaoyangguan, Mingmen, Huantiao, Ashixue. The patients in the intervention group will be classified into one of the five syndromes based on their clinical presentation and have secondary acupuncture points chosen based on their respective syndromes. There will also be additional acupuncture points for patients with neck pain, thoracic pain, and/or lumbar pain. Patients in both the intervention and control groups will be given usual care consisting of NSAIDs and/or biologics and/or physiotherapy as deemed necessary by the attending rheumatologists. Abbreviations: Acupoints acupuncture points, NSAIDs non-steroidal anti-inflammatory drugs

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