Back to resultsEfficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Knee Osteoarthritis
Primary Purpose
Osteoarthritis Knee
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standardized Acupuncture
sham acupuncture
Individualized Acupuncture
Waiting
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Knee focused on measuring Knee osteoarthritis, acupuncture, sham acupuncture
Eligibility 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
Sites / Locations
- Donnguk University Oriental Medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
No Intervention
Arm Label
Individualized acupuncture
Standardized Acupuncture
Sham acupuncture
Waiting
Arm Description
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.
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.
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.
No interventions were applied to the patients in this group. Only assessments were made at each visit.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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'.
6 Minute walk test
the distance of subject's 6 Minute walking
WOMAC pain
The pain part of WOMAC (Westren Ontario and McMaster Universities) Scale
Investigator global assessment(IGA)
5 Grading of Investigator(1=Very good, 2=good, 3=fair, 4=poor, 5=very poor)
Patient global assessment(PGA)
5 Grading of Investigator(1=Very good, 2=good, 3=fair, 4=poor, 5=very poor)
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.
Full Information
NCT ID
NCT01569230
First Posted
March 26, 2012
Last Updated
April 2, 2012
Sponsor
Eun Jung Kim
Collaborators
Semyung University, Ministry of Health & Welfare, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01569230
Brief Title
Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Knee Osteoarthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eun Jung Kim
Collaborators
Semyung University, Ministry of Health & Welfare, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Knee
Keywords
Knee osteoarthritis, acupuncture, sham acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Individualized acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Standardized Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Waiting
Arm Type
No Intervention
Arm Description
No interventions were applied to the patients in this group. Only assessments were made at each visit.
Intervention Type
Procedure
Intervention Name(s)
Standardized Acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sham acupuncture
Other Intervention Name(s)
Park Sham Device
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Individualized Acupuncture
Intervention Description
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
Intervention Type
Other
Intervention Name(s)
Waiting
Other Intervention Name(s)
No interventions
Intervention Description
No interventions were applied to the patients in this group.
Primary Outcome Measure Information:
Title
WOMAC (Western Ontario and McMaster Universities) Scale change
Description
WOMAC scale is checked by the patients. WOMAC scale is a tool to check of the disability, stiffness and pain by knee pain.
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
Secondary Outcome Measure Information:
Title
100mm Pain Visual Analogue Scale
Description
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'.
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
Title
6 Minute walk test
Description
the distance of subject's 6 Minute walking
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
Title
WOMAC pain
Description
The pain part of WOMAC (Westren Ontario and McMaster Universities) 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
Title
Investigator global assessment(IGA)
Description
5 Grading of Investigator(1=Very good, 2=good, 3=fair, 4=poor, 5=very poor)
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
Title
Patient global assessment(PGA)
Description
5 Grading of Investigator(1=Very good, 2=good, 3=fair, 4=poor, 5=very poor)
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
Title
Adverse Events
Description
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.
Time Frame
at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Jung Kim, Ph.D.
Phone
+82-31-961-9116
Email
hanijjung@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kap-Sung Kim, Ph.D.
Organizational Affiliation
Donnguk University Oriental Medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Donnguk University Oriental Medical center
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
410-773
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Jung Kim, Ph.D.
Phone
+82-31-961-9116
Email
hanijjung@naver.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
23782709
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Knee Osteoarthritis
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