Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Enrollment
- 480
- Locations
- 9
- Primary Endpoint
- Response rate
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Ping Zhou
Clinical Professor
Beijing Hospital of Traditional Chinese Medicine
Eligibility Criteria
Inclusion Criteria
- •Age 45-75 years old, male or female
- •Single / bilateral knee pain, duration of more than 6 months
- •KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ
Exclusion Criteria
- •Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)
- •Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, fracture, gout, lumbosacral vertebrae disease, etc.)
- •History of arthroscopy within 1 year or intra-articular injection within 4 months
- •History of receiving acupuncture or massage treatment within 3 months
- •Severe acute/chronic organic or mental diseases
- •Coagulation disorders (such as hemophilia, etc.)
- •Cardiac pacemaker, metal allergy or needle phobia
- •Pregnant women, pregnant and lactating women
- •Participation in another clinical study in the past 3 months
Outcomes
Primary Outcomes
Response rate
Time Frame: 8 weeks
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.
Secondary Outcomes
- Knee-joint function(baseline, 8 weeks, 16 weeks and 26 weeks)
- Knee-joint stiffness(baseline, 8 weeks, 16 weeks and 26 weeks)
- Expectancy score(1 week（after the first treatment）)
- Blinding assessment(4 weeks and 8 weeks)
- Knee-joint pain(baseline, 8 weeks, 16 weeks and 26 weeks)
- Quality of life(baseline, 8 weeks, 16 weeks and 26 weeks)
- Credibility score(1 week（after the first treatment）)
- Global effect(8 weeks, 16 weeks and 26 weeks)
- Response rate(16 weeks, 26 weeks)
- Adverse events(first treatment up to 8 weeks)