Lu-Lu Lin1,2, Yong-Ting Li3, Jian-Feng Tu1, Jing-Wen Yang1, Ning Sun1,2, Shuai Zhang1, Tian-Qi Wang1, Guang-Xia Shi1, Yi Du4, Jing-Jie Zhao4, Da-Chang Xiong5, Hai-Kun Hou5, Cun-Zhi Liu3. 1. 1 Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China. 2. 2 Department of Medicine, School of Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China. 3. 3 Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China. 4. 4 Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China. 5. 5 Department of Acupuncture and Moxibustion, Beijing Jishuitan Hospital, Peking University, Beijing, China.
Abstract
OBJECTIVE: : To evaluate the effectiveness of acupuncture for pain relief and function improvement in patients with knee osteoarthritis and to determine the feasibility of an eight-week acupuncture intervention. DESIGN: : Pilot randomized controlled trial. SETTING: : Three teaching hospitals in China. SUBJECTS: : Patients with knee osteoarthritis (Kellgren grade II or III). INTERVENTIONS: : Patients were randomly assigned to an eight-week (three sessions per week) intervention of either traditional Chinese acupuncture or sham acupuncture. MAIN MEASURES:: The primary outcome was response rate-the proportion of patients achieving score ⩾36% decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function at week 8 compared with baseline. Secondary outcomes included pain, function and quality of life. RESULTS: : Of 42 patients randomized, 36 (85.7%) completed the study. There was no significant difference in response rate between the traditional Chinese acupuncture and control groups: 61.9% (13 of 21) versus 42.9% (9 of 21) achieved score ⩾36% decrease in WOMAC pain and function at week 8 ( P = 0.217). The sum of WOMAC pain and function scores at week 8 was 11.6 (9.1) in the traditional Chinese acupuncture group compared with 16.3 (10.9) in the control group ( P = 0.183). There was no significant difference between groups. Three adverse events were recorded and were classified as mild. CONCLUSION: : It showed that three sessions per week acupuncture intervention of knee osteoarthritis was feasible and safe. No difference was observed between groups due to small sample size. Larger (sample size ⩾ 296) randomized controlled trials of this intervention appear justified.
RCT Entities:
OBJECTIVE: : To evaluate the effectiveness of acupuncture for pain relief and function improvement in patients with knee osteoarthritis and to determine the feasibility of an eight-week acupuncture intervention. DESIGN: : Pilot randomized controlled trial. SETTING: : Three teaching hospitals in China. SUBJECTS: : Patients with knee osteoarthritis (Kellgren grade II or III). INTERVENTIONS: : Patients were randomly assigned to an eight-week (three sessions per week) intervention of either traditional Chinese acupuncture or sham acupuncture. MAIN MEASURES:: The primary outcome was response rate-the proportion of patients achieving score ⩾36% decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function at week 8 compared with baseline. Secondary outcomes included pain, function and quality of life. RESULTS: : Of 42 patients randomized, 36 (85.7%) completed the study. There was no significant difference in response rate between the traditional Chinese acupuncture and control groups: 61.9% (13 of 21) versus 42.9% (9 of 21) achieved score ⩾36% decrease in WOMAC pain and function at week 8 ( P = 0.217). The sum of WOMAC pain and function scores at week 8 was 11.6 (9.1) in the traditional Chinese acupuncture group compared with 16.3 (10.9) in the control group ( P = 0.183). There was no significant difference between groups. Three adverse events were recorded and were classified as mild. CONCLUSION: : It showed that three sessions per week acupuncture intervention of knee osteoarthritis was feasible and safe. No difference was observed between groups due to small sample size. Larger (sample size ⩾ 296) randomized controlled trials of this intervention appear justified.
Entities:
Keywords:
Knee osteoarthritis; randomized controlled trial; sham acupuncture; traditional Chinese acupuncture