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| Name | Class |
|---|---|
| Semyung University | OTHER |
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized acupuncture | Experimental | 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. |
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| Standardized Acupuncture | Experimental | 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. |
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| Sham acupuncture | Sham Comparator | 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. |
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| Waiting | No Intervention | No interventions were applied to the patients in this group. Only assessments were made at each visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Acupuncture | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Jung Kim, Ph.D. | Contact | +82-31-961-9116 | hanijjung@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Kap-Sung Kim, Ph.D. | Donnguk University Oriental Medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Donnguk University Oriental Medical center | Recruiting | Goyang-si | Gyeonggi-do | 410-773 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23782709 | Derived | Kim EJ, Lim CY, Lee EY, Lee SD, Kim KS. Comparing the effects of individualized, standard, sham and no acupuncture in the treatment of knee osteoarthritis: a multicenter randomized controlled trial. Trials. 2013 May 7;14:129. doi: 10.1186/1745-6215-14-129. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| sham acupuncture | Procedure | 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 |
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| Individualized Acupuncture | Procedure | The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) |
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| Waiting | Other | No interventions were applied to the patients in this group. |
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| 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 |
| D012216 |
| Rheumatic Diseases |