Instant And Short-Term Effects Of Wrist-Ankle Acupuncture In Patients With Knee Pain(A Pilot Randomized Clinical Trial)

Objective:To investigate the instant and short-term therapeutic effects of wrist-ankle acupuncture in patients with knee painBackgroundNowadays,the most common public health problem in the world is pain.Significant number of people suffering from pain,the great medical costs,and the negative impact of pain on the quality of life are all the reasons that the treatment of pain deserves greater attention.Knee pain is one of the most common pain and musculoskeletal problem which leads to physical disability and decreases quality of life.An increasing number of patients who suffer from pain in western countries choose acupuncture as a therapeutic method,and many western scholars began to pay attention to the use of acupuncture for treatment of pain.Wrist Ankle Acupuncture(WAA),which was developed by Professor Zhang Xinshu in the 1970s and is used by several acupuncturists especially for reducing pain,is a new method of subcutaneous acupuncture.Although some surveys have confirmed the efficacy of WAA,it seems that well designed clinical trials to support the clinical effect and safety of WAA for pain is rare.Almost all articles on WAA for pain-relief are written in Chinese.There are only a few articles about wrist-ankle acupuncture in English language and international databases.Therefore the present randomized control trial would be one of the few surveys that has been done on non-Chinese patients and written in English.Our trial was designed to assess immediate and short-term(first 48 hours)effect of a single treatment of WAA acupuncture.Immediate pain reduction may have several advantages such as gaining patients' confidence in acupuncture and motivating patients to continue acupuncture treatment which is especially important in chronic pain patients,who are not often satisfied by previous ineffective treatments.Single session treatment has also some methodological advantages as many factors disturbing the internal validity of results such as natural remission of disease,would play a minor role in the study of a single treatment in comparison with multiple treatments.Wrist-ankle acupuncture is a painless method so the result of this study will be helpful in this aspect.It may be more bearable than other needling methods particularly for patients who dislike acupuncture and are afraid of it.Also,it will be a potential benefit for health policy makers because the application of WAA for the treatment of pain in clinic can largely reduce the side effects caused by using pain-killers and decrease medical cost due to the treatment of pain.In addition,it would be very useful,as immediate analgesic especially in the field of sports medicine as many analgesic drugs are in Doping list of WADA and cannot be prescribed for athletes especially during competitionsMethod:This trial was designed to assess rapid and short-term therapeutic effects of a single session of Wrist-Ankle Acupuncture.This study is a blind randomized controlled trial and was conducted from July 2017 to September 2017 at two private clinics in Tehran,Iran.When a subject was determined to be fit for participation based on inclusion and exclusion criteria,was randomly assigned to 1 of 2 groups in a ratio of 1:1:Case group who received Wrist-Ankle acupuncture and Control group who received sham acupuncture.Treatment was performed blind as neither the patient nor the evaluating person was informed about the method which was used by the acupuncturist.An outside researcher performed randomization after each participant met eligibility criteria and informed consent was obtained.The assessor was also blinded to the treatment allocation.A single acupuncturist administered the care to all subjects.Needling method in WAA group:Disposable sterile stainless steel filiform needles 0.3 mm in diameter and 40 mm in length were used.In accordance to the location of most pain in the knee,two of six of wrist-ankle acupuncture lower points were chosen.The needles were directed proximally as needles in wrist and ankle acupuncture should be directed towards the disordered area.For penetrating,the needle and the skin had form an angle of 30°.After penetration of the skin,the needle was lowered to the horizontal position and slowly advanced about 30mm in the subcutaneous tissue.The needles were retained for 40 minutes.No manipulation was done on the needles.Needling method in sham-acupuncture group:Disposable sterile stainless steel filiform needles 0.18 mm in diameter and 13 mm in length were used.Two non-acupoint at anterior of thigh at the site which no regular meridian passes(on the midline of anterior thigh,approximately 6 and 7 cun above the upper border of patella)were needled.After sterilization,the needle was inserted vertically 3-5 mm.The needles were retained for 40 minutes.No manipulation was done on the needles and after 40 minutes the needles were withdrawn.Measurements:Intensity of knee pain was measured before needling,at minute 20 during needling,at minute 40(when needling was finished)at minute 100(1 hour after removing the needles),after 24 hours and after 48 hours by The Numeric Rating Scale(NRS-11)in both groups.Pain,stiffness and functional limitation of knee were measured by WOMAC questionnaire before needling and after 48 hours.The collected data was analyzed by SPSS 23 software.Final data were imported and analyzed by a medical statistics expert who was blinded to study grouping.Statistical analysis was performed by using the SPSS version 23.Kolmogorov-Smirnov tests were used to check normal distribution of variables.Mann-Whitney-Wilcoxon was performed to compare mean values within and across 2 groups.Results:Demographic variables were evenly balanced in the process of random allocation of subjects to WA and Sham Acupuncture groups.Forty patients(mean age 51.67 years)with a mean pain duration of 3.85 years(minimum 5 days and maximum 25 years)completed this trial.Twenty four of forty patients(60%)suffered from Knee Osteoarthritis and four patients(10%)had history of ACL or meniscus rupture.Knee pain of three patients(0.75)was posttraumatic and one of them(0.25%)had post-surgical knee pain.Rapid Pain Relief:In our study,the intensity of pain which was shown by mean of numerical pain score showed a significant reduction in both groups at minute 20 after needling,but the reduction was larger in the acupuncture group(-2.4 ±1.19 points,p<0.000)than the sham group(-0.9±1.33 points,p value<0.05),which pronounces that Wrist Ankle Acupuncture can cause immediate pain reduction.NPS after 20 minutes had shown reduction in all 20 participants of WA acupuncture group and also in 8 Of 20 patients in Sham Acupuncture group.The pain score remained unchanged until the needles were retained at 40 minutes which shows that retaining the needles more than 20 minutes in the body may not cause more pain reduction.After one hour NPS still was significantly lower than baseline in both groups(-2.55±1.14 points,p<0.000 in WA ACUPUNCTURE group and-0.55±1.1 points,p value<0.05 in Sham group).Short-Term Pain Relief:The changes of NPS from baseline were significant in WA Acupuncture group after 24 hours(-1.6±1.85,p<0.01)but not after 48 hours.In Sham Acupuncture group,Changes in NPS were not significant after 24 hours and 48 hours.These results suggest that wrist ankle acupuncture may have short-term pain reduction effect at least until 24 hours.yet,the pain reduction of Sham Acupuncture last only some hours.Total score of WOMAC:Total score of WOMAC at 48 hours after needling significantly decreased in both group(P-value<0.0001 in WAA group and P-value<0.05 in Sham group).However the change was high significantly more in WA Acupuncture group.(P-value<0.001).WOMAC Pain Subscale:Pain subscale score of WOMAC measured at 48 hours after needling,significantly decreased in both group(P-value<0.0001 in WAA group and P-value<0.05 in Sham group).However the change was high significantly more in WA Acupuncture group.(p-value<0.005).WOMAC Stiffness subscale:Unlike control group,in the Wrist-Ankle acupuncture group,WOMAC stiffness subscale score decreased significantly and the changes between two groups were significant(P-value<0.005)which shows that WA Acupuncture may reduce stiffness in patients with knee pain.WOMAC hysical function subscale:In contrast with the Wrist-Ankle acupuncture group,WOMAC Physical Function subscale decreased significantly and the change was higher than control group(p-value<0.001)which manifests that WAA has positive effects on physical function of patients with knee pain.Adverse events:In this trial no adverse event happened in any of the groups.Conclusion:A single session of WA acupuncture may relieve pain immediately and the effect will remain at least for 24 hours.Although Sham-acupuncture can cause immediate pain reduction,the effect is less and remains only for some hours.Furthermore WAA can decrease stiffness and improve physical function in patients with knee pain.WAA deserves from health policy makers to pay more attention and it is worthy of clinical promotion.