PMID- 33080693
OWN - NLM
STAT- MEDLINE
DCOM- 20201030
LR  - 20221005
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 99
IP  - 42
DP  - 2020 Oct 16
TI  - The long-term effect of acupuncture for patients with knee osteoarthritis: Study 
      protocol for a randomized controlled trial.
PG  - e22599
LID - 10.1097/MD.0000000000022599 [doi]
LID - e22599
AB  - INTRODUCTION: Whether there is the long-term effect of acupuncture on patients 
      with knee osteoarthritis (KOA) or not is controversial. According to the basic 
      theory of traditional acupuncture, deqi is the key to the efficacy of 
      acupuncture. This randomized controlled trial aims to evaluate the existence of 
      long-term effects caused by deqi in patients with KOA. METHODS AND ANALYSIS: A 
      three-armed, parallel-design, randomized controlled trial is underway in 
      China.108 KOA patients recruited by the rehabilitation center of the First 
      Affiliated Hospital of Henan University of Traditional Chinese Medicine will be 
      randomly assigned to the acupuncture with deqi group (A group), the acupuncture 
      without deqi group (B group) and the waiting-list group (C group). Each patient 
      will receive 5 30-minute sessions per week for 4 consecutive weeks and rest for 2 
      days between treatments, and undergo a 20-week follow-up. The primary outcome is 
      the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score). 
      The secondary outcomes include Western Ontario and McMaster Universities 
      Osteoarthritis index (WOMAC score), Knee Injury and Osteoarthritis Outcome Score 
      (KOOS), arthritis quality of life measurement scale simplified scale (AIMS2-SF), 
      emotional monitoring and expectation scale. The pain visual analogue scale (VAS) 
      and the Chinese version of modified Massachusetts General Hospital Acupuncture 
      Sensation Scale (C-MMASS) will be used to evaluate the deqi sensation after each 
      acupuncture treatment. At the same time, adverse events (AEs) occurred in the 
      whole process will be recorded and analyzed. We will perform an 
      intention-to-treat analysis and protocol (PP) analysis to statistically analyze 
      the results of the trial. DISCUSSION: This trial will be useful to study the 
      long-term effect of acupuncture and the influence of the deqi sensation on the 
      long-term in the treatment of KOA, and to provide a clinical basis for treatment 
      of patients with mild to moderate knee osteoarthritis in clinic. TRIAL 
      REGISTRATION: Chinese Clinical Trial Registry, IDF: ChiCTR2000029291. Registered 
      on January 21, 2020.
FAU - Wu, Nan
AU  - Wu N
AD  - School of Rehabilitation Medicine, Henan University of Chinese Medicine.
FAU - Huang, Jin
AU  - Huang J
AD  - School of Rehabilitation Medicine, Henan University of Chinese Medicine.
FAU - Yang, Xuguang
AU  - Yang X
AD  - School of Rehabilitation Medicine, Henan University of Chinese Medicine.
FAU - Guo, Jian
AU  - Guo J
AD  - The Rehabilitation Center, First Affiliated Hospital of Henan University of 
      Chinese Medicine.
FAU - Liu, Feilai
AU  - Liu F
AD  - The Rehabilitation Center, First Affiliated Hospital of Henan University of 
      Chinese Medicine.
FAU - Gu, Yujing
AU  - Gu Y
AD  - The Rehabilitation Center, First Affiliated Hospital of Henan University of 
      Chinese Medicine.
FAU - Liu, Yongtao
AU  - Liu Y
AD  - The Rehabilitation Center, First Affiliated Hospital of Henan University of 
      Chinese Medicine.
FAU - Zhang, Zhenhua
AU  - Zhang Z
AD  - School of Rehabilitation Medicine, Henan University of Chinese Medicine.
FAU - Yin, Shuai
AU  - Yin S
AD  - The Rehabilitation Center, First Affiliated Hospital of Henan University of 
      Chinese Medicine.
FAU - Feng, Xiaodong
AU  - Feng X
AD  - The Rehabilitation Center, First Affiliated Hospital of Henan University of 
      Chinese Medicine.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
SB  - IM
MH  - *Acupuncture Therapy
MH  - Humans
MH  - Osteoarthritis, Knee/*therapy
MH  - Randomized Controlled Trials as Topic
PMC - PMC7572014
COIS- The authors have no conflicts of interests to disclose.
EDAT- 2020/10/22 06:00
MHDA- 2020/10/31 06:00
PMCR- 2020/10/16
CRDT- 2020/10/21 01:01
PHST- 2020/10/21 01:01 [entrez]
PHST- 2020/10/22 06:00 [pubmed]
PHST- 2020/10/31 06:00 [medline]
PHST- 2020/10/16 00:00 [pmc-release]
AID - 00005792-202010160-00026 [pii]
AID - MD-D-20-07983 [pii]
AID - 10.1097/MD.0000000000022599 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2020 Oct 16;99(42):e22599. doi: 
      10.1097/MD.0000000000022599.