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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by DongGuk University.
Recruitment status was  Recruiting
Sponsor:
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
  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:

  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:

  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 autoimmune 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by DongGuk University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 26, 2014