Quotation Kwan, Yu Heng, Fong, Warren, Ang, Xiang Ling, Tan, Chuen Seng, Tai, Bee Choo, Huang, Youyi, Phang, Jie Kie, Tan, Hui Chin, Lee, Jia Ven, Sun, Limin, Tan, Choy Tip, Dong, Bao Qiang, Koh, Hwee Ling, Lui, Nai Lee, Yeo, Siaw Ing, Ng, Swee Cheng, Fong, Kok Yong, Thumboo, Julian, Østbye, Truls, Bilger, Marcel. 2019. Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial. Trials. 20 (1)


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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.

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Publication's profile

Status of publication Published
Affiliation External
Type of publication Journal article
Journal Trials
Citation Index SCI
Language English
Title Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial
Volume 20
Number 1
Year 2019
DOI http://dx.doi.org/10.1186/s13063-018-3117-2
Open Access Y
Open Access Link https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-018-3117-2

Associations

People
Bilger, Marcel (Details)
External
Ang, Xiang Ling (Singapore Thong Chai Medical Institution, Singapore)
Dong, Bao Qiang (Liaoning University of Traditional Chinese Medicine, Singapore)
Fong, Kok Yong (Singapore General Hospital, Singapore)
Fong, Warren (National University of Singapore, Singapore)
Huang, Youyi (SingHealth, Singapore)
Koh, Hwee Ling (National University of Singapore, Singapore)
Kwan, Yu Heng (Duke-NUS Medical School, Singapore)
Lee, Jia Ven (Singapore Thong Chai Medical Institution, Singapore)
Lui, Nai Lee (Singapore General Hospital,, Singapore)
Ng, Swee Cheng (Singapore General Hospital, Singapore)
Østbye, Truls (Duke-NUS Medical School, Singapore)
Phang, Jie Kie (Singapore General Hospital, Singapore)
Sun, Limin (Singapore Thong Chai Medical Institution, Singapore)
Tai, Bee Choo (National University of Singapore, Singapore)
Tan, Choy Tip (Singapore Thong Chai Medical Institution, Singapore)
Tan, Chuen Seng (National University of Singapore, Singapore)
Tan, Hui Chin (Singapore Thong Chai Medical Institution, Singapore)
Thumboo, Julian (Duke-NUS Medical School, Singapore)
Yeo, Siaw Ing (Singapore General Hospital, Singapore)
Organization
Health Economics and Policy Group AB (Details)
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