ClinicalTrials.gg
Status unknownNCT01569230Updated Apr 4, 2012

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

An interventional study of Standardized Acupuncture and sham acupuncture in Osteoarthritis Knee, sponsored by Eun Jung Kim. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-04.

Sponsored by Eun Jung Kim · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of — 13 open to participants now, 21 under way, 4 of them phase 3. Osteoarthritis, Knee · Korea, Republic of.

Planned enrollment
21st of 85
250 · median 124
Started
2010
with 4 others
No phase
26 of 96
6 open now
Registered
18th of 96
by date

Among the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of, this one is the 21st largest by planned enrollment of the 85 interventional ones that give a count, is one of 5 that started in 2010, is one of 26 with no phase, and was the 18th registered.

Osteoarthritis, Knee

3,294 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

13 of the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of are open now. Recruiting first, the newest first:

8 more — sign in →

All 13 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 383 Osteoarthritis, Knee studies recruiting now, 177 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 20 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Osteoarthritis Knee

Keywords

  • Knee osteoarthritis
  • acupuncture
  • sham acupuncture
04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. At least 20 years of age, but below 80 years of age
  2. Knee pain from OA in one or both knees in the last 3 months or more
  3. Presence of knee OA diagnosed by an orthopedist based on American College of Rheumatology classification criteria
  4. Knee pain from OA in one or both knees rated > 4 cm on a 10 cm Visual Analog Scale (VAS)
  5. An understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form.
  6. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months

Exclusion criteria

Exclusion Criteria:

  1. Trauma to or surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems
  2. A history of prolotherapy, injection of hyaluronic acid or cortisone within the last 3 months
  3. A physical or laboratory finding indicating infection, presence of an disease, or inflammatory arthritis
  4. Serious organic disease, and severe dysfunction due to the medical illness (e.g. Arrhythmia, Angina pectoris, Stroke, Asthma, etc.)
  5. More severe pain in regions other than the knee joint.
  6. Pregnant
  7. When researchers evaluate that it is not appropriate to participate in this clinical test
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • No intervention
    Waiting

    No interventions were applied to the patients in this group. Only assessments were made at each visit.

    Other: Waiting

Interventions

  • ProcedureStandardized 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.

  • Proceduresham 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

    Also known as: Park Sham Device

  • ProcedureIndividualized Acupuncture

    The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)

  • OtherWaiting

    No interventions were applied to the patients in this group.

    Also known as: No interventions

06

What researchers measure

Primary outcomes

  1. 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.

    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 outcomes

  1. 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'.

    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

  2. 6 Minute walk test

    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

  3. WOMAC pain

    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

  4. Investigator global assessment(IGA)

    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

  5. Patient global assessment(PGA)

    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

  6. 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.

    Time frame: at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit

07

Study locations

1 of 1 sites recruiting
  • Donnguk University Oriental Medical center
    Goyang, Gyeonggi-do 410-773, Korea, Republic of
    Recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010, a primary completion of Aug 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2012
First posted
Apr 3, 2012
Start
Oct 2010
Primary completionEst.
Aug 2012
CompletionEst.
Dec 2012
Last update
Apr 4, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01569230
Lead sponsor
Eun Jung Kim
Collaborators
Semyung University, Ministry of Health & Welfare, Korea
Responsible party
Eun Jung Kim (Research professor, DongGuk University) — Sponsor-investigator
First posted
Apr 3, 2012
Start date
Oct 2010
Primary completion
Aug 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Apr 4, 2012

Study contacts

Eun Jung Kim, Ph.D.
Contact
hanijjung@naver.com
+82-31-961-9116
Kap-Sung Kim, Ph.D.
principal investigator · Donnguk University Oriental Medical center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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