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

• Published in: Current controlled trials in cardiovascular medicine 2019-12, Vol.20 (1), p.673-673, Article 673
• Main Authors: Fu, Yuan-Bo, Li, Bin, Sun, San-Feng, Liu, Hui-Lin, Wang, Xin, Wang, Shao-Song, Zhang, Fan, Du, Xin, Ge, Du-Juan, Shang, Lei, Liang, Rui-Li, Wang, Li-Na, Yuan, Fang, Sun, Jing-Qing, Chen, Jun-Wei
• Format: Article
• Language: English
• Subjects: Acupuncture; Acupuncture Therapy - methods; Adult; Aged; Aged, 80 and over; Arthritis; Basic health management; Care and treatment; Chinese medicine; Clinical trials; Evidence-based medicine; Female; Fire Acupuncture; Humans; Interleukins; Knee; Knee Osteoarthritis; Male; Middle Aged; Multicenter Studies as Topic; Necrosis; Osteoarthritis; Osteoarthritis, Knee - therapy; Pilot Projects; Prospective Studies; Randomized Controlled Trials as Topic; Research Design; Study Protocol; Tumor necrosis factor-TNF; Tumors; Universities and colleges
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3744-2

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