Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial
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 stu...
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| Format: | Article |
| Language: | English |
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BMC
2019-01-01
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| Series: | Trials |
| Online Access: | http://link.springer.com/article/10.1186/s13063-018-3117-2 |
| _version_ | 1818557377731887104 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Yu Heng Kwan |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T23:58:41Z |
| format | Article |
| id | doaj.art-a7449226e44d4a8aaa14bd7952aa542a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T23:58:41Z |
| publishDate | 2019-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a7449226e44d4a8aaa14bd7952aa542a2022-12-21T23:26:27ZengBMCTrials1745-62152019-01-0120111110.1186/s13063-018-3117-2Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trialYu Heng Kwan0Warren Fong1Xiang Ling Ang2Chuen Seng Tan3Bee Choo Tai4Youyi Huang5Marcel Bilger6Jie Kie Phang7Hui Chin Tan8Jia Ven Lee9Limin Sun10Choy Tip Tan11Bao Qiang Dong12Hwee Ling Koh13Ying Ying Leung14Nai Lee Lui15Siaw Ing Yeo16Swee Cheng Ng17Kok Yong Fong18Julian Thumboo19Truls Østbye20Program in Health Services and Systems Research, Duke-NUS Medical SchoolDepartment of Rheumatology and Immunology, Singapore General HospitalSingapore Thong Chai Medical InstitutionSaw Swee Hock School of Public Health, National University of SingaporeSaw Swee Hock School of Public Health, National University of SingaporeInternal Medicine Residency, SingHealthProgram in Health Services and Systems Research, Duke-NUS Medical SchoolDepartment of Rheumatology and Immunology, Singapore General HospitalSingapore Thong Chai Medical InstitutionSingapore Thong Chai Medical InstitutionSingapore Thong Chai Medical InstitutionSingapore Thong Chai Medical InstitutionLiaoning University of Traditional Chinese MedicineDepartment of Pharmacy, National University of SingaporeDepartment of Rheumatology and Immunology, Singapore General HospitalDepartment of Rheumatology and Immunology, Singapore General HospitalDepartment of Rheumatology and Immunology, Singapore General HospitalDepartment of Rheumatology and Immunology, Singapore General HospitalDepartment of Rheumatology and Immunology, Singapore General HospitalProgram in Health Services and Systems Research, Duke-NUS Medical SchoolProgram in Health Services and Systems Research, Duke-NUS Medical SchoolAbstract 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.http://link.springer.com/article/10.1186/s13063-018-3117-2 |
| spellingShingle | 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 Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial Trials |
| title | Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial |
| title_full | Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial |
| title_fullStr | Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial |
| title_full_unstemmed | Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial |
| title_short | Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial |
| title_sort | traditional chinese medicine tcm collaborative care for patients with axial spondyloarthritis acuspa protocol for a pragmatic randomized controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-018-3117-2 |
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