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

Abstract

BackgroundAxial 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/designThis 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.DiscussionThis trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of a TCMCMC for patients with AxSpA.Trial registrationClinicalTrials.gov, NCT03420404. Registered on 14 February 2018.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3117-2) contains supplementary material, which is available to authorized users.

Facilitators of and barriers to implementing a traditional Chinese medicine collaborative model of care for axial spondyloarthritis: a qualitative study

“…Details of the RCT can be found in the protocol. 8 Briefly, we recruited patients with active axSpA with inadequate response to NSAIDs, who did not receive biologic treatment within the 3 months prior to the point of recruitment. The recruited patients were randomised into either the collaborative care (intervention) arm or the usual care (control) arm.…”

“…Therefore, we are conducting an RCT that aims to evaluate the effectiveness of a TCM collaborative model of care (TCMCMC) involving acupuncture for patients with axSpA. 8 However, quantitative research alone cannot thoroughly provide a full understanding of the feasibility of the TCMCMC. 9 Thus, this qualitative study nested within the RCT aimed to explore participants' perceptions of the feasibility of the TCMCMC, specifically the facilitators of and barriers to implementing a TCMCMC involving acupuncture for patients with axSpA.…”

To assess weather the external application of traditional Chinese medicine can promote the trabecular bone regeneration and callus fibrous transformation by regulating IL-1, BMP2, TNF-α, TGF and other serum biochemical index AKP.

“…Closed fracture in traditional Chinese medicine can be ascribed to "bone broken tendon injury" category, its pathogenesis is roughly qi and blood not free, blood stasis block, meridians and muscles and bones are damaged to cause pain, swelling. Therefore, the treatment should be based on activating qi to relieve pain, activating blood circulation to remove blood stasis and replenish bones, and regulating qi [6]. Traditional Chinese medicine compound refers to a prescription made of at least two Chinese herbs, which has relatively prescriptive processing methods and usage methods [7].…”