The cerebral mechanism of the specific and nonspecific effects of acupuncture based on knee osteoarthritis: study protocol for a randomized controlled trial
Autor: | You-Sheng Qi, Jun-Hong Liu, Chao-Qun Yan, Jin-Ling Li, Na Zhang, Li-Qiong Wang, Lu-Lu Lin, Cun-Zhi Liu, Xu Wang, Jian-Feng Tu |
---|---|
Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Male
medicine.medical_specialty China WOMAC Functional magnetic resonance imaging Acupuncture Therapy Medicine (miscellaneous) Osteoarthritis Placebo law.invention 03 medical and health sciences Study Protocol 0302 clinical medicine Specific effect Randomized controlled trial Rating scale law medicine Acupuncture Humans Pain Management Pharmacology (medical) 030212 general & internal medicine Aged Pain Measurement Randomized Controlled Trials as Topic Nonspecific effect lcsh:R5-920 business.industry Brain Middle Aged Osteoarthritis Knee medicine.disease Arthralgia Magnetic Resonance Imaging Clinical trial Treatment Outcome Physical therapy Anxiety Female Knee osteoarthritis medicine.symptom business lcsh:Medicine (General) 030217 neurology & neurosurgery |
Zdroj: | Trials, Vol 21, Iss 1, Pp 1-10 (2020) Trials |
ISSN: | 1745-6215 |
Popis: | Background Research on the effect of acupuncture has been limited. Whether the effect of acupuncture is equivalent to placebo has been the focus of debate in this field. This study will explore the specific and non-specific effects of acupuncture for knee osteoarthritis (KOA) by functional magnetic resonance imaging (fMRI). Methods and design Ninety participants diagnosed with KOA will be randomly divided into the acupuncture group, sham acupuncture group, and waiting list group in a ratio of 1:1:1. Except for the waiting list group, the other participants will receive acupuncture or sham acupuncture three sessions per week for 4 weeks respectively. The primary outcome will be the response rate which is defined on an individual basis as at least a 2-point decrease in the numerical rating scale (NRS) of pain at the end of intervention period compared with the baseline. fMRI scans will be performed at baseline and the end of the intervention period to examine the response of various brain regions. The secondary outcomes will include the Western Ontario and McMaster Osteoarthritis Index (WOMAC), State-Trait Anxiety Scale-State Anxiety Subscale (STAI-S), and Stanford Expectations of Treatment Scale (SETS). Pearson’s correlation coefficient will be performed to investigate the changes in brain activity and clinical variables. Discussion The results of our study will help to evaluate the specific and nonspecific effects of acupuncture combined with clinical and brain function changes based on KOA. Trial registration Chinese Clinical Trial Registry ChiCTR1900025799. Registered on 9 September 2019. |
Databáze: | OpenAIRE |
Externí odkaz: | |
Nepřihlášeným uživatelům se plný text nezobrazuje | K zobrazení výsledku je třeba se přihlásit. |