Acupuncture Therapy for Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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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 NRS ≥ 4 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electro-acupuncture<br>5 compulsory acupoints (ST35、EX-LE5、LR8、GB33 and Ashi) and 3 optional matching acupoints (stomach meridian syndrome：ST34、ST36、ST32、ST40、EX-LE2；gallbladder meridian syndrome：GB31、GB36、GB34、GB39、GB41；bladder meridian syndrome：BL39、BL40、BL57、BL60；San Yin meridian syndrome：LR7、SP9、SP10、KI10、SP4、SP6、LR3、KI3) will be chosen. Needles will be stimulated manually to achieve De Qi sensation and an electrical apparatus (Nanjing Jisheng Medical Co., Ltd., wave of 2/100Hz) will be then connected to the needles with alligator clips in pairs LR8-GB33 and two other matching acupoints. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity. Patients will receive 30-minute, 24 sessions intervention over eight weeks. | Other: acupuncture<br>* acupuncture is a therapy of traditional Chinese medicine，in which acupuncturist puncture the patient's skin at specific acupoints with needle.<br>|
| Experimental: manual acupuncture<br>Participants in the manual acupuncture group have the same schedule as the Electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output. | Other: acupuncture<br>* acupuncture is a therapy of traditional Chinese medicine，in which acupuncturist puncture the patient's skin at specific acupoints with needle.<br>|
| Sham Comparator: sham acupuncture<br>Those in the sham acupuncture group receive shallow acupuncture at non-acupoints without manipulation，Deqi or actual current output. | Other: acupuncture<br>* acupuncture is a therapy of traditional Chinese medicine，in which acupuncturist puncture the patient's skin at specific acupoints with needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | baseline, 8 weeks, 16 weeks and 26 weeks | 
| Credibility score | using Credibility/expectancy questionnaire | 1 week（after the first treatment） | 
| Expectancy score | using Credibility/expectancy questionnaire | 1 week（after the first treatment） | 
| Blinding assessment | Blinding assessment will be performed in all 9 centers | 4 weeks and 8 weeks | 
| Global effect | Overall Treatment Effect (extremely improved, slightly improved, not changed, slightly aggravated, extremely aggravated) | 8 weeks, 16 weeks and 26 weeks | 
| Adverse events | Adverse Event Form | first treatment up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoarthritis, acupuncture, electroacupuncture, sham acupuncture