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Published in: Trials 1/2019

Open Access 01-12-2019 | Acupuncture | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2019

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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.
Appendix
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Metadata
Title
Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial
Authors
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
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3117-2

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