Fire acupuncture for mild to moderate knee osteoarthritis: a protocol for a randomized controlled pilot trial
| Autor: | Bin Li, Shao-Song Wang, Du-Juan Ge, Rui-Li Liang, Lei Shang, Jing-Qing Sun, Hui-Lin Liu, Li-Na Wang, Yuan-Bo Fu, Fang Yuan, Fan Zhang, Jun-Wei Chen, San-Feng Sun, Xin Wang, Xin Du |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Acupuncture Therapy Medicine (miscellaneous) Pilot Projects Osteoarthritis 03 medical and health sciences Study Protocol Knee Osteoarthritis 0302 clinical medicine medicine Acupuncture Clinical endpoint Humans Pharmacology (medical) 030212 general & internal medicine Clinical efficacy Prospective Studies Fire Acupuncture Tumor necrosis factor α Aged Randomized Controlled Trials as Topic 030203 arthritis & rheumatology Protocol (science) Aged 80 and over lcsh:R5-920 business.industry Pilot trial Basic health management Middle Aged Osteoarthritis Knee medicine.disease Clinical trial Research Design Physical therapy Female business lcsh:Medicine (General) |
| Zdroj: | Trials Trials, Vol 20, Iss 1, Pp 1-8 (2019) |
| ISSN: | 1745-6215 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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