NCT01569230

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

March 26, 2012

Last Update Submit

April 2, 2012

Conditions

Osteoarthritis Knee

Keywords

Knee osteoarthritisacupuncturesham acupuncture

Outcome Measures

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.

    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

    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

    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

    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)

    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)

    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

  • +1 more secondary outcomes

Study Arms (4)

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.

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.

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.

Procedure: sham acupuncture

Waiting

NO INTERVENTION

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

Other: Waiting

Interventions

Standardized AcupuncturePROCEDURE

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.

Standardized Acupuncture
sham acupuncturePROCEDURE

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
Sham acupuncture
Individualized AcupuncturePROCEDURE

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

Individualized acupuncture
WaitingOTHER

No interventions were applied to the patients in this group.

Also known as: No interventions
Waiting

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Donnguk University Oriental Medical center

Goyang-si, Gyeonggi-do, 410-773, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23782709DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kap-Sung Kim, Ph.D.

    Donnguk University Oriental Medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Jung Kim, Ph.D.

CONTACT

+82-31-961-9116hanijjung@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research professor

Study Record Dates

First Submitted

March 26, 2012

First Posted

April 3, 2012

Study Start

October 1, 2010

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

KR(1)