A Randomized Controlled Pilot Trial Of Acupuncture Treatment For Knee Osteoarthriti

Objective:Osteoarthritis is one of the most common musculoskeletal diseases,and is a major cause of elder people disability.Acupuncture is widely used in treating musculoskeletal diseases in China.But up to now,there is little evidence-basedmedicine,high-quality evidence of the effectiveness of acupuncture treating knee osteoarthritis.The preliminary trial aims to evaluate the clinical effectiveness of Traditional Chinese Acupuncture treating knee osteoarthritis,to provide data support for estimating sample size of formal trial,and to determine the feasibility of comparing traditional acupuncture with minimal acupuncture.Methods:42 eligible participants were randomly assigned to TCA group(n=21)and MA group(n=21)by blocked randomization.The 26-week trial included a 8-week treatment and a 18-week follow-up.Treatments were delivered 3 sessions weekly for 8 weeks,with 24 sessions in total.The primary end point is success rate,which will be calculated according to a change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain and function scores at 8 weeks.Secondary end points include pain and function measurement,the quality of life at 8,16 and 26 weeks after randomization..Result:178 participants were preliminary screened via telephone,42 participants were identified as eligible,and were assigned to TCA group(n=21)and MA group(n=21)randomly.1 patient in TCA group(on a business trip)and 1 patient in MA group(lack of effectiveness)dropped the acupuncture treatment before 8 weeks,with a dropout rate of 4.76%in total.13(61.90%)patients in TCA group and 9(42.86%)patients in MA group improved 36%from baseline in WOMAC index,with no significant difference between two groups(P>0.217).Considering the small sample size and insufficient power,we transform response rate to NNT(5.3),with prominent clinical significance.Furthermore,there were no significant differences between two groups in almost secondary outcomes(WOMAC pain subscale,WOMAC function subscale,VAS,SF-12 at 8 weeks,16 weeks and 26 weeks after randomization.3 side-effects were reported by 2 patients in TCA group(one small haematoma,one post-needling sensation)and 1 patient in MA group(post-needling sensation),with no significant difference between two groups(P>0.549).No serious adverse event reported.Conclusions:The effective response rate of TCA group is higher than MA group,with significant clinical difference but no statistical difference for the small sample size.The next plan is to implement a clinical trial with a large sample size,to furtherly determine the clinical effect of TCA treating knee osteoarthritis.Both dropout rate and lost to follow-up rate of this trial are lower than international requirements,with no serious adverse event reported,which comes to the conclusion that the trial protocol is safe and feasible.