Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to verify the efficacy and safety of acupuncture treatments (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).

Detailed Description
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The investigators targeted the patients with knee OA. After treatment in 4 groups - individualized acupuncture treatment, standardized acupuncture treatment, sham-needle treatment, and waiting groups - the investigators will compare the effects of pain relieving and daily performing improvement. So the investigators will confirm the efficacy of acupuncture, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Official Title
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Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Knee Osteoarthritis Patients: Randomized, Single-blind, Controlled Study

Conditions
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Osteoarthritis Knee

Intervention / Treatment
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* Procedure: Standardized Acupuncture
* Procedure: sham acupuncture
* Procedure: Individualized Acupuncture
* Other: Waiting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 20 years of age, but below 80 years of age Knee pain from OA in one or both knees in the last 3 months or more Presence of knee OA diagnosed by an orthopedist based on American College of Rheumatology classification criteria Knee pain from OA in one or both knees rated > 4 cm on a 10 cm Visual Analog Scale (VAS) An understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months Exclusion Criteria: Trauma to or surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems A history of prolotherapy, injection of hyaluronic acid or cortisone within the last 3 months A physical or laboratory finding indicating infection, presence of an autoimmune disease, or inflammatory arthritis Serious organic disease, and severe dysfunction due to the medical illness (e.g. Arrhythmia, Angina pectoris, Stroke, Asthma, etc.) More severe pain in regions other than the knee joint. Pregnant When researchers evaluate that it is not appropriate to participate in this clinical test

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Individualized acupuncture<br>The patients in this group received individualized acupuncture prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on the pattern diagnosis, which is an unique diagnosis system of Oriental Medicine. | Procedure: Individualized Acupuncture<br>* The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)<br>|
| Experimental: Standardized Acupuncture<br>The patients in this group received standardized acupuncture treatment using the same acupuncture points, applied by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience. The acupuncture formulas were composed based on literature review of RCTs. | Procedure: Standardized Acupuncture<br>* The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 9 Acupuncture points(SP9,GB34, ST36, ST35, Xiyan(EX-LE5), BL60, GB39, SP6 and KI3)were used for all the patients assigned to this group. Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used.<br>|
| Sham Comparator: Sham acupuncture<br>Non-penetrating acupuncture device, Park-sham acupuncture, was applied to the patients. The appearance of the acupuncture is same but the needles do not penetrate the skin. | Procedure: sham acupuncture<br>* The treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 9 same acupuncture points as in the standardized acupuncture group. Each session was 20 minutes long<br>* Other names: Park Sham Device;|
| No Intervention: Waiting<br>No interventions were applied to the patients in this group. Only assessments were made at each visit. | Other: Waiting<br>* No interventions were applied to the patients in this group.<br>* Other names: No interventions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC (Western Ontario and McMaster Universities) Scale change | WOMAC scale is checked by the patients. WOMAC scale is a tool to check of the disability, stiffness and pain by knee pain. | at 2nd(Baseline),8(after 3weeks of treatment),13th(after 6 weeks of treatment) and 14(follow up evaluation after 6 weeks from the last treatment) visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100mm Pain Visual Analogue Scale | The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'. | at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13(after 6 weeks of treatment), and 14th(follow up evaluation after 6 weeks from the last treatment) visit | 
| 6 Minute walk test | the distance of subject's 6 Minute walking | at 2nd(Baseline),8(after 3weeks of treatment),13th(after 6 weeks of treatment) and 14(follow up evaluation after 6 weeks from the last treatment) visit | 
| WOMAC pain | The pain part of WOMAC (Westren Ontario and McMaster Universities) Scale | at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13(after 6 weeks of treatment), and 14th(follow up evaluation after 6 weeks from the last treatment) visit | 
| Investigator global assessment(IGA) | 5 Grading of Investigator(1=Very good, 2=good, 3=fair, 4=poor, 5=very poor) | at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13(after 6 weeks of treatment), and 14th(follow up evaluation after 6 weeks from the last treatment) visit | 
| Patient global assessment(PGA) | 5 Grading of Investigator(1=Very good, 2=good, 3=fair, 4=poor, 5=very poor) | at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13(after 6 weeks of treatment), and 14th(follow up evaluation after 6 weeks from the last treatment) visit | 
| Adverse Events | Any unpredicted symptoms were checked at each follow up visit and if any, the symptom, time of occurrence, and length of duration were recorded and reported. | at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit | 

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