Sinew acupuncture for knee osteoarthritis: study protocol for a randomized sham-controlled trial

Kwok Yin Au, Haiyong Chen, Wing Chung Lam, Chiu On Chong, Andrew Lau, Varut Vardhanabhuti, Kin Cheung Mak, Fei Jiang, Wing Yi Lam, Fung Man Wu, Hiu Ngok Chan, Yan Wah Ng, Bacon Fung-Leung Ng, Eric Tat-Chi Ziea, Lixing Lao, Kwok Yin Au, Haiyong Chen, Wing Chung Lam, Chiu On Chong, Andrew Lau, Varut Vardhanabhuti, Kin Cheung Mak, Fei Jiang, Wing Yi Lam, Fung Man Wu, Hiu Ngok Chan, Yan Wah Ng, Bacon Fung-Leung Ng, Eric Tat-Chi Ziea, Lixing Lao

Abstract

Background: Sinew acupuncture is a new modality of acupuncture in which needles are inserted into acupoints, ashi points or spasm points of sinew and muscles along the meridian sinew pathway. A previous observational study revealed that sinew acupuncture has immediate analgesic effects on various soft tissue injuries, including knee injuries. However, no rigorous trials have been conducted. This study aims to examine whether sinew acupuncture can safely relieve pain and symptoms of knee osteoarthritis (KOA) and improve patients' functional movement and quality of life.

Methods/design: A randomized, sham-controlled, patient- and assessor-blinded trial will be conducted to compare the efficacy of sinew acupuncture and sham acupuncture. Subjects will be assessed by the physician and acupuncturists. A sample of eighty-six eligible subjects will be randomized into either the sinew acupuncture group or the sham acupuncture group. The intervention will be performed in the Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong by acupuncturists with over 3 years of acupuncture experience. Subjects will receive 10 sessions of interventions for 4 weeks, followed by a 6-week follow-up. The visual analogue scale (VAS) score at week 4 will be the primary outcome. The Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed Up & Go Test (TUG), 8-step Stair Climb Test (SCT) and the 36-Item Short Form Survey (SF-36) will be secondary outcomes.

Discussion: Sinew acupuncture is a potential alternative non-pharmacological therapy for KOA. This rigorous trial will expand our knowledge of whether sinew acupuncture reduces pain intensity and improves symptoms, functional movements, and quality of life of KOA patients.

Trial registration: The study was registered at ClinicalTrials.gov (Identifier: NCT03099317) in March 2017.

Keywords: Knee osteoarthritis; Pain; Protocol; Randomized controlled trial; Sham acupuncture; Sinew acupuncture.

Conflict of interest statement

Ethics approval and consent to participate

This trial was designed to meet the standards of the International Committee on Harmonization on Good Clinical Practice and the Declaration of Helsinki. It has been peer reviewed and approved by the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster (UW 16–2007). Participants will provide written informed consent prior to enrolment.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram of the study protocol. Assessment measures will be performed as follows: (1) Pain: VAS (visual analogue scale) and WOMAC (Western Ontario & McMasters University Osteoarthritis Index); (2) Functional movement: TUG (Timed up & Go Test) and 8-step SCT (Stair Climb Test); (3) Quality of life: Short Form-36 (SF-36); (4) Credibility test (end of weeks 2 & 4); (5) Test of blinding success (end of week 4); (6) Patient diary (weekly)

References

    1. Johnson VL, Hunter DJ. The epidemiology of osteoarthritis. Best Pract Res Clin Rheumatol. 2014;28(1):5–15. doi: 10.1016/j.berh.2014.01.004.
    1. Guccione AA, Felson DT, Anderson JJ, Anthony JM, Zhang Y, Wilson PW, Kelly-Hayes M, Wolf PA, Kreger BE, Kannel WB. The effects of specific medical conditions on the functional limitations of elders in the Framingham study. Am J Public Health. 1994;84(3):351–358. doi: 10.2105/AJPH.84.3.351.
    1. Fransen M, Bridgett L, March L, Hoy D, Penserga E, Brooks P. The epidemiology of osteoarthritis in Asia. Int J Rheum Dis. 2011;14(2):113–121. doi: 10.1111/j.1756-185X.2011.01608.x.
    1. Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, et al. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(7):1323–1330. doi: 10.1136/annrheumdis-2013-204763.
    1. Felson DT, Naimark A, Anderson J, Kazis L, Castelli W, Meenan RF. The prevalence of knee osteoarthritis in the elderly. The Framingham osteoarthritis study. Arthritis Rheum. 1987;30(8):914–918. doi: 10.1002/art.1780300811.
    1. Zhang Y, Xu L, Nevitt MC, Aliabadi P, Yu W, Qin M, Lui LY, Felson DT. Comparison of the prevalence of knee osteoarthritis between the elderly Chinese population in Beijing and whites in the United States: the Beijing osteoarthritis study. Arthritis Rheum. 2001;44(9):2065–2071. doi: 10.1002/1529-0131(200109)44:9<2065::AID-ART356>;2-Z.
    1. March LM, Bachmeier CJ. Economics of osteoarthritis: a global perspective. Baillieres Clin Rheumatol. 1997;11(4):817–834. doi: 10.1016/S0950-3579(97)80011-8.
    1. Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009;15(8 Suppl):S230–S235.
    1. Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthr Cartil. 2013;21(9):1145–1153. doi: 10.1016/j.joca.2013.03.018.
    1. Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, et al. OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthr Cartil. 2008;16(2):137–162. doi: 10.1016/j.joca.2007.12.013.
    1. Witt C, Brinkhaus B, Jena S, Linde K, Streng A, Wagenpfeil S, Hummelsberger J, Walther HU, Melchart D, Willich SN. Acupuncture in patients with osteoarthritis of the knee: a randomised trial. Lancet. 2005;366(9480):136–143. doi: 10.1016/S0140-6736(05)66871-7.
    1. Berman BM, Lao LX, Langenberg P, Lee WL, Gilpin AMK, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee - a randomized, controlled trial. Ann Intern Med. 2004;141(12):901–910. doi: 10.7326/0003-4819-141-12-200412210-00006.
    1. Hinman RS, McCrory P, Pirotta M, Relf I, Forbes A, Crossley KM, Williamson E, Kyriakides M, Novy K, Metcalf BR, et al. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA. 2014;312(13):1313–1322. doi: 10.1001/jama.2014.12660.
    1. Scharf HP, Mansmann U, Streitberger K, Witte S, Kramer J, Maier C, Trampisch HJ, Victor N. Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med. 2006;145(1):12–20. doi: 10.7326/0003-4819-145-1-200607040-00005.
    1. MacPherson H, Vertosick E, Lewith G, Linde K, Sherman KJ, Witt CM, Vickers AJ, Acupuncture Trialists C. Influence of control group on effect size in trials of acupuncture for chronic pain: a secondary analysis of an individual patient data meta-analysis. PLoS One. 2014;9(4):e93739. doi: 10.1371/journal.pone.0093739.
    1. Chen HY, Ning ZP, Lam WL, Lam WY, Zhao YK, Yeung JWF, Ng BF-L, Ziea ETC, Lao LX. Types of control in acupuncture clinical trials might affect the conclusion of the trials: a review of acupuncture on pain management. J Acupunct Meridian. 2016;9(5):227–233. doi: 10.1016/j.jams.2016.08.001.
    1. Corbett MS, Rice SJC, Madurasinghe V, Slack R, Fayter DA, Harden M, Sutton AJ, MacPherson H, Woolacott NF. Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis. Osteoarthr Cartilage. 2013;21(9):1290–1298. doi: 10.1016/j.joca.2013.05.007.
    1. Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K, Trialists’ A. Acupuncture for chronic pain individual patient data meta-analysis. Arch Intern Med. 2012;172(19):1444–1453. doi: 10.1001/archinternmed.2012.3654.
    1. MacPherson H, Vertosick EA, Foster NE, Lewith G, Linde K, Sherman KJ, Witt CM, Vickers AJ. The persistence of the effects of acupuncture after a course of treatment: a meta-analysis of patients with chronic pain. Pain. 2017;158(5):784–793. doi: 10.1097/j.pain.0000000000000747.
    1. Liu NY. Getting qi and arrival of qi. Zhongguo Zhen Jiu. 2014;34(8):828–830.
    1. Liu N. Jingjin and weiqi. Zhongguo Zhen Jiu. 2015;35(2):185–188.
    1. Liu N. Exploration and analysis on the mechanism of sinew acupuncture. Zhongguo Zhen Jiu. 2015;35(12):1293–1296.
    1. Ting H. Academic theory of sinew acupuncture by professor Liu Nongyu. Zhongguo Zhen Jiu. 2015;(s1):56–8.
    1. Legge D. Acupuncture treatment of chronic low back pain by using the Jingjin (meridian sinews) model. J Acupunct Meridian. 2015;8(5):255–258. doi: 10.1016/j.jams.2015.07.013.
    1. Wei S, Chen ZH, Sun WF, Zhang GP, Li XH, Hou CF, Lu LD, Zhang L. Evaluating meridian-sinew release therapy for the treatment of knee osteoarthritis. Evid Based Complement Alternat Med. 2013;2013:182528.
    1. Zhao H, Nie WB, Sun YX, Li S, Yang S, Meng FY, Zhang LP, Wang F, Huang SX. Warm needling therapy and acupuncture at meridian-sinew sites based on the meridian-sinew theory: hemiplegic shoulder pain. Evid Based Complement Alternat Med. 2015;2015:694973.
    1. Chen YM, Zhao Y, Xue XL, Zhang QC, Wu XY, Li H, Zheng X, Zhao JN, He FD, Kong JH, et al. Distribution characteristics of meridian sinew (Jingjin) syndrome in 313 cases of whiplash-associated disorders. Chin J Integr Med. 2015;21(3):234–240. doi: 10.1007/s11655-014-1955-7.
    1. Liu N, Liu H. Sinew Acupuncture. Beijing: Peoples's Medical Publishing House; 2016.
    1. Liu N, Ren T, Xiang Y. Immediate analgesic effects of tendon acupuncture on soft tissue injury. Zhongguo Zhen Jiu. 2015;35(9):927–929.
    1. Vas J, Rebollo A, Perea-Milla E, Mendez C, Font CR, Gomez-Rio M, Martin-Avila M, Carbrera-Iboleon J, Caballero MD, Olmos M, et al. Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine. BMC Complem Altern Med. 2008;8:12.
    1. Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983;70(1):41–55. doi: 10.1093/biomet/70.1.41.
    1. Jiang F, Tian L, Fu H, Hasegawa T, Pfeffer MA, Wei L. Robust alternatives to ANCOVA for estimating the treatment effect via a randomized comparative study. 2016.

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