Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common bone and joint diseases in clinic. It was estimated to affect more than 9 million individuals in the United States in 2005 and is a leading cause of disability and medical costs. Most elderly people over the age of 65 have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or disability. Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needles are placed into the body at specific points. Studies have shown that acupuncture can stimulate nerves under the skin, causing the body to produce natural pain-relieving substances (endorphins). However the evidences of acupuncture for KOA are contradictory. According to the review, intensive acupuncture with three sessions a week is more effective for KOA than sparse acupuncture with one session a week. Moreover, the papers published in the past years suggest that manual acupuncture and electro-acupuncture are most commonly used acupuncture therapy for the treatment of knee osteoarthritis. The aim of this study is to evaluate the efficacy of intensive electro-acupuncture or manual acupuncture versus sham acupuncture in reducing pain and improving function in patients with KOA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
480
acupuncture is a therapy of traditional Chinese medicine，in which acupuncturist puncture the patient's skin at specific acupoints with needle.
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
Beijing, Beijing Municipality, China
Guang'an Men Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Beijing Hospital of Traditional Chinese and Western Medicine
Beijing, Beijing Municipality, China
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Hospital of acupuncture-Moxibustion, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijin, Beijing Municipality, China
Affiliated Hospital of Hebei University of Chinese Medicine
Hebei, Hebei, China
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Response rate
the percentage of patients with improvement in average pain (numerical rating scale, NRS) at least 2 units and in Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) function subscale score at least 6 units at 8 weeks. Pain NRS was a self-administered instrument, a number selected from 0-10 by participant. Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain. The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
Time frame: 8 weeks
Response rate
the percentage of patients with improvement in average pain (numerical rating scale, NRS) at least 2 units and in Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) function subscale score at least 6 units at 16 and 26 weeks. Pain NRS was a self-administered instrument, a number selected from 0-10 by participant. Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain. The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
Time frame: 16 weeks, 26 weeks
Knee-joint pain
using numerical rating scale (NRS). NRS was a self-administered instrument, a number selected from 0-10 by participant. Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.
Time frame: baseline, 8 weeks, 16 weeks and 26 weeks
Knee-joint pain
using WOMAC pain subscale. The WOMAC pain subscale referred to the patient's pain. It was comprised of 5 items, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst pain condition. An overall score range of 0 (minimum) to 20 (maximum), with higher scores indicating worse physical function.
Time frame: baseline, 8 weeks, 16 weeks and 26 weeks
Knee-joint function
using WOMAC function subscale. The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
Time frame: baseline, 8 weeks, 16 weeks and 26 weeks
Knee-joint stiffness
using WOMAC stiffness subscale. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.
Time frame: baseline, 8 weeks, 16 weeks and 26 weeks
Quality of life
using 12-Item Short Form Health Survey. An overall score range of 0 (minimum) to 100(maximum), with higher scores indicating better quality of life.
Time frame: baseline, 8 weeks, 16 weeks and 26 weeks
Credibility score
using Credibility/expectancy questionnaire
Time frame: 1 week（after the first treatment）
Expectancy score
using Credibility/expectancy questionnaire
Time frame: 1 week（after the first treatment）
Blinding assessment
Blinding assessment will be performed in all 9 centers
Time frame: 4 weeks and 8 weeks
Global effect
Overall Treatment Effect (extremely improved, slightly improved, not changed, slightly aggravated, extremely aggravated)
Time frame: 8 weeks, 16 weeks and 26 weeks
Adverse events
Adverse Event Form
Time frame: first treatment up to 8 weeks
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