Evaluating The Effectiveness Of Chinese Herbs By Iontophoresis And Application On Acupoints For Knee Osteoarthritis Pain:a Randomized Controlled Trial

OBJECTIVETo evaluate the effectiveness of Chinese herbs by iontophoresis and application on acupoints for knee osteoarthritis pain through a multi-center randomized controlled trial and provide reliable clinical trial basis for operation scheme of traditional Chinese medicine external treatment of knee osteoarthritis.METHODSA multi-center, randomized and controlled trial was designed.117 knee osteoarthritis patients who matched the inclusion and exclusion criteria were randomly divided into 2 groups. Participants in treatment group received Chinese herbs by iontophoresis and application on acupoints. Participants in control group received dichofenac diethylammon by iontophoresis and ketoprofen patch. Participants received treatment once per day and totally for 14 days. The primary outcome was the pain intensity, pain frequency, the duration of the pain; The secondary outcome was the tenderness index, joint function and quality of life. Based on the comparison before and after treatment in the group and comparison between groups after treatment of each outcome, to evaluate the effectiveness of traditional Chinese medicine external treatment for knee osteoarthritis pain.Result1.Baseline:The base lines of the 2 groups showed no significant difference(P>0.05).2. All the pain-related outcomes of treatment group was significantly improved after the treatment (P<0.01).?the total score, the score of "walk" and "up and down the mountain" of WOMAC score of pain intensity in treatment group was significantly lower than control group after treatment (P<0.05); the improvement of 2 groups had no significant difference(P>0.05). the pain intensity of treatment group was significantly lower than control group at 4-14th day (P<0.05); the average percentage of pain relief of treatment group was significantly higher than control group (P<0.01); the percentage of pain relief of treatment group was significantly better than control group at 8-14th day(P<0.05); the time pain relief began of the 2 groups showed no significant difference(P>0.05); the ratio of pain disappeared of treatment group was significantly better than control group (P<0.05).? The pain frequency of treatment group was significantly lower than control group at 7th,14th day (P<0.05); the improvement in the pain frequency of treatment group was significantly higher than control group(P<0.05).?The duration of the pain of treatment group was significantly lower than control group at 14th day (P<0.05); the improvement in duration of the pain of 2 groups had no significant difference(P>0.05).3.All the disease-related outcomes of treatment group was significantly improved after the treatment (P<0.01).? the tenderness index of treatment group was significantly lower than control group at 3th,7th day (P<0.05); the improvement of 2 groups had no significant difference(P>0.05).?the WOMAC score of joint function of treatment group was significantly better than control group at 7th and 14th day(P<0.05); the improvement of 2 groups had no significant difference(P>0.05).?the AIMS2-SFscore and symptom of treatment group was significantly better than control group at 14th day(P<0.05); the improvement in AIMS2-SFscore, physical function.work and symptom of treatment group were significantly higher than control group(P<0.05).4.All the follow-up outcomes were significantly better than baseline (P<0.01). AIMS2-SFscore of treatment group was significantly better than control group at 12th and 24th week after treatment(P<0.05) while the pain frequency, WOMAC score of pain intensity and physical functionat 12th week only(P<0,05).6.There is no serious adverse event in 2 groups. The compliance of 2 groups well above 90%. The safety and compliance of 2 groups all had no significant difference(P>0.05).CONCLUSION1.The Chinese herbs by iontophoresis and application on acupoints can effectively improve the symptoms of pain, joint function and quality of life for patients with knee osteoarthritis with satisfying long-term effects.It is better than herapeutic schedule of Western medicine in reducing the pain intensity and frequency, improving the average of percentage of pain relief, the ratio of pain disappeared and quality of life.2. The therapy with strong clinical applicability is safe, effective and easy to operate.