Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Knee Osteoarthritis
This study is currently recruiting participants.
Verified April 2012 by DongGuk University
Sponsor:
Eun Jung Kim
Collaborators:
Semyung University
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Eun Jung Kim, DongGuk University
ClinicalTrials.gov Identifier:
NCT01569230
First received: March 26, 2012
Last updated: April 2, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to verify the efficacy and safety of acupuncture treatments (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).
| Condition | Intervention |
|---|---|
|
Osteoarthritis Knee |
Procedure: Standardized Acupuncture Procedure: sham acupuncture Procedure: Individualized Acupuncture Other: Waiting |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Knee Osteoarthritis Patients: Randomized, Single-blind, Controlled Study |
Resource links provided by NLM:
Further study details as provided by DongGuk University:
Primary Outcome Measures:
- WOMAC (Western Ontario and McMaster Universities) Scale change [ Time Frame: 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 ] [ Designated as safety issue: No ]WOMAC scale is checked by the patients. WOMAC scale is a tool to check of the disability, stiffness and pain by knee pain.
Secondary Outcome Measures:
- 100mm Pain Visual Analogue Scale [ Time Frame: 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 ] [ Designated as safety issue: No ]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'.
- 6 Minute walk test [ Time Frame: 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 ] [ Designated as safety issue: No ]the distance of subject's 6 Minute walking
- WOMAC pain [ Time Frame: 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 ] [ Designated as safety issue: No ]The pain part of WOMAC (Westren Ontario and McMaster Universities) Scale
- Investigator global assessment(IGA) [ Time Frame: 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 ] [ Designated as safety issue: No ]5 Grading of Investigator(1=Very good, 2=good, 3=fair, 4=poor, 5=very poor)
- Patient global assessment(PGA) [ Time Frame: 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 ] [ Designated as safety issue: No ]5 Grading of Investigator(1=Very good, 2=good, 3=fair, 4=poor, 5=very poor)
- Adverse Events [ Time Frame: at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 250 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Individualized acupuncture
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
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
Other Name: Individualized Acupuncture
|
|
Experimental: Standardized Acupuncture
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
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.
Other Name: Standardized Acupuncture
|
|
Sham Comparator: Sham acupuncture
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
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
Other Name: Park Sham Device
|
|
No Intervention: Waiting
No interventions were applied to the patients in this group. Only assessments were made at each visit.
|
Other: Waiting
No interventions were applied to the patients in this group.
Other Name: No interventions
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569230
Contacts
| Contact: Eun Jung Kim, Ph.D. | +82-31-961-9116 | hanijjung@naver.com |
Locations
| Korea, Republic of | |
| Donnguk University Oriental Medical center | Recruiting |
| Goyang, Gyeonggi-do, Korea, Republic of, 410-773 | |
| Contact: Eun Jung Kim, Ph.D. +82-31-961-9116 hanijjung@naver.com | |
Sponsors and Collaborators
Eun Jung Kim
Semyung University
Ministry of Health & Welfare, Korea
Investigators
| Principal Investigator: | Kap-Sung Kim, Ph.D. | Donnguk University Oriental Medical center |
More Information
No publications provided
| Responsible Party: | Eun Jung Kim, Research professor, DongGuk University |
| ClinicalTrials.gov Identifier: | NCT01569230 History of Changes |
| Other Study ID Numbers: | B080017-KCT0000385 |
| Study First Received: | March 26, 2012 |
| Last Updated: | April 2, 2012 |
| Health Authority: | South Korea: Institutional Review Board Korea: Ministry for Health, Welfare and Family Affairs |
Keywords provided by DongGuk University:
|
Knee osteoarthritis acupuncture sham acupuncture |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013