Top

Published in:

Open Access 01-12-2019 | Knee Osteoarthritis | Study protocol

Fire acupuncture for mild to moderate knee osteoarthritis: a protocol for a randomized controlled pilot trial

Authors: Yuan-Bo Fu, Bin Li, San-Feng Sun, Hui-Lin Liu, Xin Wang, Shao-Song Wang, Fan Zhang, Xin Du, Du-Juan Ge, Lei Shang, Rui-Li Liang, Li-Na Wang, Fang Yuan, Jing-Qing Sun, Jun-Wei Chen

Published in: Trials | Issue 1/2019

Abstract

Background

Knee osteoarthritis (KOA) is one of the most common bone and joint diseases. As one of the main non-drug therapies, acupuncture is widely used to treat KOA, although the evidence for its efficacy is inconclusive. The objective of this pilot trial is to clarify the clinical efficacy and safety of fire acupuncture in the treatment of mild to moderate KOA and to provide high-quality data for further research.

Methods/design

This study is a prospective randomized controlled pilot trial in which 120 patients with mild to moderate KOA will be randomly allocated in equal proportions to a fire acupuncture group or a general acupuncture group. They will receive acupuncture for six sessions over 2 weeks. The primary end point is success rate, which will be calculated based on the change from baseline of the pain and function scores in the Western Ontario and McMaster Universities Osteoarthritis Index at 4 weeks. Secondary end points include the proportion of patients achieving clinical improvement based on: (1) the OMERACT-OARSI responder criteria, (2) levels of matrix metalloproteinase 3, interleukin 1β, and tumor necrosis factor α in blood, and (3) a subjective efficacy evaluation from patients.

Trial registration

Chinese Clinical Trial Registry, ChiCTR1800019162. Registered on 29 October 2018.

Available only for authorised users

Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012;64(4):465–74.CrossRef

Mavrommatis CI, Argyra E, Vadalouka A, et al. Acupuncture as an adjunctive therapy to pharmacological treatment in patients with chronic pain due to osteoarthritis of the knee: a 3-armed, randomized, placebo-controlled trial. Pain. 2012;153(8):1720–6. https://doi.org/10.1016/j.pain.2012.05.005.CrossRefPubMed

O'Neill TW, McCabe PS, McBeth J. Update on the epidemiology, risk factors and disease outcomes of osteoarthritis. Best Pract Res Clin Rheumatol. 2018;32(2):312–26. https://doi.org/10.1016/j.berh.2018.10.007 [published Online First: 2018/12/12].CrossRefPubMed

Goldring MB, Goldring SR. Osteoarthritis. J Cell Physiol. 2007;213(3):626–34. https://doi.org/10.1002/jcp.21258.CrossRefPubMed

Baker K, McAlindon T. Exercise for knee osteoarthritis. Curr Opin Rheumatol. 2000;12(5):456–63.CrossRef

Higgs R. Osteoarthritis: Concentrated efforts to detect early OA. Nat Rev Rheumatol. 2010;6(11):616. https://doi.org/10.1038/nrrheum.2010.165.CrossRefPubMed

Brown GA. AAOS clinical practice guideline: treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013;21(9):577–9. https://doi.org/10.5435/JAAOS-21-09-577.CrossRefPubMed

National Clinical Guideline Centre. Osteoarthritis: Care and Management in Adults. London; 2014. https://www.ncbi.nlm.nih.gov/pubmed/25340227.

Wu JN. A short history of acupuncture. J Altern Complement Med. 1996;2(1):19–21. https://doi.org/10.1089/act.1996.2.19.CrossRefPubMed

10.

China National Standardization Administration SAoQS, Inspection and Quarantine. Standardized manipulations of acupuncture and moxibustion-Part 12:Fire acupuncture. Beijing: Standards Press of China; 2009.

11.

Wang Y, Xie X, Zhu X, et al. Fire-needle moxibustion for the treatment of knee osteoarthritis: a meta-analysis. Evidence-Based Complement Alternat Med. 2016;2016:1392627. https://doi.org/10.1155/2016/1392627.CrossRef

12.

Hu QS, Zhang QR, Jia CS, et al. Clinical randomized controlled observation of the treatment of senile knee osteoarthritis with needle acupuncture and its effect on inflammatory cytokines in knee joint cavity. Acupuncture Research. 2011;(02):110-5.

13.

Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. https://doi.org/10.1136/bmj.c332.CrossRefPubMedPubMedCentral

14.

MacPherson H, Altman DG, Hammerschlag R, et al. Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261. https://doi.org/10.1371/journal.pmed.1000261.CrossRefPubMedPubMedCentral

15.

Liu CZ, Xie JP, Wang LP, et al. A randomized controlled trial of single point acupuncture in primary dysmenorrhea. Pain Med. 2014;15(6):910–20. https://doi.org/10.1111/pme.12392.CrossRefPubMed

16.

Bellamy N, Buchanan WW, Goldsmith CH, et al. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–40.

17.

Goldsmith CH, Boers M, Bombardier C, et al. Criteria for clinically important changes in outcomes: development, scoring and evaluation of rheumatoid arthritis patient and trial profiles. OMERACT Committee. J Rheumatol. 1993;20(3):561–5.PubMed

18.

Gobbi A, Lad D, Karnatzikos G. The effects of repeated intra-articular PRP injections on clinical outcomes of early osteoarthritis of the knee. Knee Surg Sports Traumatol Arthrosc. 2015;23(8):2170–7. https://doi.org/10.1007/s00167-014-2987-4.CrossRefPubMed

19.

Aigner T, Kim HA. Apoptosis and cellular vitality: issues in osteoarthritic cartilage degeneration. Arthritis Rheum. 2002;46(8):1986–96. https://doi.org/10.1002/art.10554.CrossRefPubMed

Title: Fire acupuncture for mild to moderate knee osteoarthritis: a protocol for a randomized controlled pilot trial
Authors: Yuan-Bo Fu
Bin Li
San-Feng Sun
Hui-Lin Liu
Xin Wang
Shao-Song Wang
Fan Zhang
Xin Du
Du-Juan Ge
Lei Shang
Rui-Li Liang
Li-Na Wang
Fang Yuan
Jing-Qing Sun
Jun-Wei Chen
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Knee Osteoarthritis
Acupuncture
Knee Osteoarthritis
Published in: Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-3744-2

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Fire acupuncture for mild to moderate knee osteoarthritis: a protocol for a randomized controlled pilot trial

Abstract

Background

Methods/design

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/design

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2019

Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial

Scopolamine augmentation of a newly initiated escitalopram treatment for major depressive disorder: study protocol for a randomized controlled trial

Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial

Online Social anxiety Cognitive therapy for Adolescents (OSCA): protocol for a randomised controlled trial

Efficacy of motivating short interventions for smokers in primary care (COSMOS trial): study protocol for a cluster-RCT

Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial