Osteoarthritis Of Knee Clinical Trial
Official title:
Efficacy of Electro-acupuncture Versus Manual Acupuncture for Knee Osteoarthritis: a Randomized Controlled Pilot Trial
Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common bone and joint diseases in clinic. It often occurs in middle-aged people, especially women. 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.According to the papers published in the past years, we find that acupuncture therapy for the treatment of knee osteoarthritis include manual acupuncture, electro-acupuncture, acupotomy, laser acupuncture, fire needle and so on, among which manual acupuncture and electro-acupuncture are most commonly used.The aim of this study is to compare the effectiveness of electro-acupuncture and manual acupuncture in reducing pain and improving function in patients with KOA.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | February 28, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age 45-75 years old, male or female - Single / bilateral knee pain, duration of more than 6 months - KL (Kellgren-Lawrence) grade ? or ? - VAS = 40mm - Signed informed consent Exclusion Criteria: - Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy) - History of arthroscopy within 1 year or intra-articular injection within 4 months - Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.) - Severe acute/chronic organic or mental diseases - Coagulation disorders (such as hemophilia, etc.) - Pregnant women, pregnant and lactating women - History of receiving acupuncture or massage treatment within one month - Participation in another clinical study in the past 3 months - With a cardiac pacemaker, metal allergy or needle phobia |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
zhouping | Beijing Friendship Hospital, Beijing Jishuitan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success Rate | a change of 50% from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and function scores at 8 weeks. | baseline, 8 weeks | |
Secondary | Pain | using WOMAC pain subscale | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks | |
Secondary | Stiffness | using WOMAC stiffness subscale | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks | |
Secondary | Knee-joint function | using WOMAC functional subscale | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks | |
Secondary | Quality of life | using the 12-Item Short Form Health Survey (SF-12) | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks | |
Secondary | Number of emergency analgesics (Celebrex/Loxonin) used | using Drug Use Form | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks | |
Secondary | Inflammatory markers | Luminex liquid chip method (LuminexxMAP, Technology, USA) Bio-plex200 system high throughput analysis platform (Bio-Rad) will be used to detect the expression of free protein in serum. Patients will receive fasting blood samples in the morning and then be centrifuged with 3000r/min, 15min in two hours. | baseline, 8 weeks | |
Secondary | Credibility/expectancy questionnaires | Credibility/expectancy questionnaires are used to assess the credibility and expectancy of the patients | baseline | |
Secondary | Adverse events | using Adverse Event Form | up to 16 weeks |
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