Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial

doi:10.1186/s13063-019-3481-6

. 2019 Jun 24;20(1):377.

doi: 10.1186/s13063-019-3481-6.

Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial

Bao-Ping Xu^{1

2}, Min Yao^{1

3}, Zi-Rui Tian^{1

3}, Long-Yun Zhou^{1

3}, Long Yang^{1

4}, Zhen-Jun Li^{1

5}, Sen Zhu^{1

6}, Xiao-Tao Wang⁷, Jia-Hui Lan⁸, Yong-Jun Wang^{1

3}, Xue-Jun Cui^{9

10}

Affiliations

¹ Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, China.
² Lu'an Hospital of Traditional Chinese Medicine, 76 Renmin Road, Anhui, 237000, Lu'an, China.
³ Key Laboratory of Theory and Therapy of Muscles and Bones, Ministry of Education (Shanghai University of Traditional Chinese Medicine), 725 South Wanping Road, Shanghai, 200032, China.
⁴ Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, 540 Xinhua Road, Shanghai, 200052, China.
⁵ Gansu Provincial Hospital of Traditional Chinese Medicine, 418 Guazhou Road, Qi lihe District, Gansu, 730050, Lanzhou, China.
⁶ Department of Orthopaedic, Shanghai Pudong Gongli Hospital, Second Military Medical University, 219 Miaopu Road, Shanghai, 200013, China.
⁷ Ehu Branch of Xishan People's Hospital, No. 1 Xuehai East Road, Xishan District, Wuxi, 214116, Jiangsu, China.
⁸ Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, China.
⁹ Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, China. 13917715524@139.com.
¹⁰ Key Laboratory of Theory and Therapy of Muscles and Bones, Ministry of Education (Shanghai University of Traditional Chinese Medicine), 725 South Wanping Road, Shanghai, 200032, China. 13917715524@139.com.

PMID: 31234919
PMCID: PMC6591844
DOI: 10.1186/s13063-019-3481-6

Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial

Bao-Ping Xu et al. Trials. 2019.

. 2019 Jun 24;20(1):377.

doi: 10.1186/s13063-019-3481-6.

Authors

Affiliations

¹ Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, China.
² Lu'an Hospital of Traditional Chinese Medicine, 76 Renmin Road, Anhui, 237000, Lu'an, China.
³ Key Laboratory of Theory and Therapy of Muscles and Bones, Ministry of Education (Shanghai University of Traditional Chinese Medicine), 725 South Wanping Road, Shanghai, 200032, China.
⁴ Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, 540 Xinhua Road, Shanghai, 200052, China.
⁵ Gansu Provincial Hospital of Traditional Chinese Medicine, 418 Guazhou Road, Qi lihe District, Gansu, 730050, Lanzhou, China.
⁶ Department of Orthopaedic, Shanghai Pudong Gongli Hospital, Second Military Medical University, 219 Miaopu Road, Shanghai, 200013, China.
⁷ Ehu Branch of Xishan People's Hospital, No. 1 Xuehai East Road, Xishan District, Wuxi, 214116, Jiangsu, China.
⁸ Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, China.
⁹ Spine Disease Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, China. 13917715524@139.com.
¹⁰ Key Laboratory of Theory and Therapy of Muscles and Bones, Ministry of Education (Shanghai University of Traditional Chinese Medicine), 725 South Wanping Road, Shanghai, 200032, China. 13917715524@139.com.

PMID: 31234919
PMCID: PMC6591844
DOI: 10.1186/s13063-019-3481-6

Abstract

Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affects quality of life. Patients with KOA frequently develop one or more of the following typical symptoms: joint pain, stiffness, joint friction noise and impaired functionality. Traditional Chinese medicine (TCM) has been shown to have a superior effect and a particular advantage in the treatment of KOA; among TCM, the Tong-luo Qu-tong plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high-quality clinical evidences to support the therapeutic effect that Chinese adhesive plaster can have in relieving pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-tong plaster in patients with KOA.

Methods/design: This study will be a randomized, double-blind, parallel positive controlled, multi-center clinical trial, a non-inferiority trial design was adopted. A total of 2000 participants older than 40 years, with KOA, will be randomly allocated into an experimental group (n = 1500) and a control group (n = 500). All participants will receive a conventional conservative treatment lasting for 14 days as two courses, once daily. Tong-luo Qu-tong plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score and visual analog scale scores will be measured during the assessment visits (baseline and 1-week and 2-week follow up). In addition, adverse events related to clinical symptoms and signs and results of laboratory tests will be documented during the clinical trials.

Discussion: This study will provide reliable evidence of the effectiveness and safety of Tong-luo Qutong plaster in patients with KOA. If the results are favorable, it is expected that the patients with KOA will benefit from this study, many patients may have a good alternative treatment for KOA.

Trial registration: ClinicalTrials.gov, ID: NCT03309501 . Registered on 8 November 2017.

Keywords: Clinical trials; Knee osteoarthritis; Protocol; Randomized; Tong-luo Qu-tong plaster.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
Study phases schedule of the randomized controlled trial for patients

**Fig. 2**
Study flow diagram of trial participation

See this image and copyright information in PMC

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References

1. Cucchiarini M, de Girolamo L, Filardo G, Oliveira JM, Orth P, Pape D, et al. Basic science of osteoarthritis. J Exp Orthop. 2016;3(1):22. doi: 10.1186/s40634-016-0060-6. - DOI - PMC - PubMed
1. Herrero-Beaumont G, Roman-Blas JA, Bruyere O, Cooper C, Kanis J, Maggi S, et al. Clinical settings in knee osteoarthritis: pathophysiology guides treatment. Maturitas. 2017;96:54–57. doi: 10.1016/j.maturitas.2016.11.013. - DOI - PubMed
1. Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012;64(6):1697–1707. doi: 10.1002/art.34453. - DOI - PMC - PubMed
1. Liu Y, Zhang H, Liang N, Fan W, Li J, Huang Z, et al. Prevalence and associated factors of knee osteoarthritis in a rural Chinese adult population: an epidemiological survey. BMC Public Health. 2016;16:94. doi: 10.1186/s12889-016-2782-x. - DOI - PMC - PubMed
1. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646–656. - PMC - PubMed

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[1] Cucchiarini M, de Girolamo L, Filardo G, Oliveira JM, Orth P, Pape D, et al. Basic science of osteoarthritis. J Exp Orthop. 2016;3(1):22. doi: 10.1186/s40634-016-0060-6. - DOI - PMC - PubMed

[2] Cucchiarini M, de Girolamo L, Filardo G, Oliveira JM, Orth P, Pape D, et al. Basic science of osteoarthritis. J Exp Orthop. 2016;3(1):22. doi: 10.1186/s40634-016-0060-6. - DOI - PMC - PubMed

[3] Herrero-Beaumont G, Roman-Blas JA, Bruyere O, Cooper C, Kanis J, Maggi S, et al. Clinical settings in knee osteoarthritis: pathophysiology guides treatment. Maturitas. 2017;96:54–57. doi: 10.1016/j.maturitas.2016.11.013. - DOI - PubMed

[4] Herrero-Beaumont G, Roman-Blas JA, Bruyere O, Cooper C, Kanis J, Maggi S, et al. Clinical settings in knee osteoarthritis: pathophysiology guides treatment. Maturitas. 2017;96:54–57. doi: 10.1016/j.maturitas.2016.11.013. - DOI - PubMed

[5] Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012;64(6):1697–1707. doi: 10.1002/art.34453. - DOI - PMC - PubMed

[6] Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012;64(6):1697–1707. doi: 10.1002/art.34453. - DOI - PMC - PubMed

[7] Liu Y, Zhang H, Liang N, Fan W, Li J, Huang Z, et al. Prevalence and associated factors of knee osteoarthritis in a rural Chinese adult population: an epidemiological survey. BMC Public Health. 2016;16:94. doi: 10.1186/s12889-016-2782-x. - DOI - PMC - PubMed

[8] Liu Y, Zhang H, Liang N, Fan W, Li J, Huang Z, et al. Prevalence and associated factors of knee osteoarthritis in a rural Chinese adult population: an epidemiological survey. BMC Public Health. 2016;16:94. doi: 10.1186/s12889-016-2782-x. - DOI - PMC - PubMed

[9] Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646–656. - PMC - PubMed

[10] Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646–656. - PMC - PubMed

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Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial

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Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial

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