Osteoarthritis KneeNCT01569230
Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Knee Osteoarthritis
A study testing Standardized Acupuncture, Individualized Acupuncture and Waiting in people with Osteoarthritis Knee, run by Eun Jung Kim at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Osteoarthritis Knee
- What is being tested?
- Standardized Acupuncture, Individualized Acupuncture and Waiting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Donnguk University Oriental Medical center
Goyang-si, Gyeonggi-do, 410-773
Eun Jung Kim, Ph.D., +82-31-961-9116, hanijjung@naver.com
About this study
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
The purpose of this study is to verify the efficacy and safety of acupuncture treatments (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).
Read the 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.
- Conditions
- Osteoarthritis Knee
- Being tested
- Standardized Acupuncture, sham acupuncture, Individualized Acupuncture, Waiting
- Keywords
- Knee osteoarthritis, acupuncture, sham acupuncture
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized AcupunctureProcedure or surgery
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.
sham acupunctureProcedure or surgery
Also called Park Sham Device
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
Individualized AcupunctureProcedure or surgery
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
WaitingOther
Also called No interventions
No interventions were applied to the patients in this group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Individualized Acupuncture |
| 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. Receives: Procedure: Standardized Acupuncture |
| 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. Receives: Procedure: sham acupuncture |
| Waiting | No intervention | No interventions were applied to the patients in this group. Only assessments were made at each visit. Receives: Other: Waiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (6)
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'.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startOct 2010
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eun Jung Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Semyung University, Ministry of Health & Welfare, Korea
- Responsible party
- Sponsor-investigator, Eun Jung Kim, DongGuk University
- Investigators
- Kap-Sung Kim, Ph.D., Principal investigator, Donnguk University Oriental Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569230
- Sponsor's protocol ID
- B080017-KCT0000385
- Status last verified
- Apr 2012
- First submitted
- 26 Mar 2012
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23782709
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01569230
- Acronym / sponsor ID
- B080017-KCT0000385
- Conditions
- Osteoarthritis Knee
- Keywords
- Knee osteoarthritis, acupuncture, sham acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Eun Jung KimUniversity, hospital or other
- Collaborators
- Semyung University, Ministry of Health & Welfare, Korea
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individualized acupuncture | Experimental | Procedure: Individualized AcupunctureThe 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. |
| Standardized Acupuncture | Experimental | Procedure: Standardized AcupunctureThe 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. |
| Sham acupuncture | Sham comparator | Procedure: sham acupunctureNon-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. |
| Waiting | No intervention | Other: WaitingNo interventions were applied to the patients in this group. Only assessments were made at each visit. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized AcupunctureThe 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. | Procedure or surgery | Standardized Acupuncture |
| sham acupunctureAlso: Park Sham DeviceThe 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 | Procedure or surgery | Sham acupuncture |
| Individualized AcupunctureThe treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) | Procedure or surgery | Individualized acupuncture |
| WaitingAlso: No interventionsNo interventions were applied to the patients in this group. | Other | Waiting |
Primary outcome
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
WOMAC scale is checked by the patients. WOMAC scale is a tool to check of the disability, stiffness and pain by knee pain.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
- Derived from this study: PubMed 23782709Kim 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kap-Sung Kim, Ph.D. principal investigator
Donnguk University Oriental Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Acupuncture, Individualized Acupuncture and Waiting in people with Osteoarthritis Knee, run by Eun Jung Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Jung Kim, Ph.D. (+82-31-961-9116, hanijjung@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2012.