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

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).

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis Knee
• Intervention / Treatment: Procedure: Individualized Acupuncture; Other: Waiting; Procedure: Standardized Acupuncture; Procedure: sham acupuncture

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eun Jung Kim, Ph.D.; Phone Number: +82-31-961-9116; Email: hanijjung@naver.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang, Gyeonggi-do, Korea, Republic of, 410-773
      • Recruiting
      • Donnguk University Oriental Medical center
      • Contact: Eun Jung Kim, Ph.D.; Phone Number: +82-31-961-9116; Email: hanijjung@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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 Names: 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 Names: No 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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	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	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)	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)	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.	at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit

Collaborators and Investigators

• Sponsor: Eun Jung Kim
• Collaborators: Ministry of Health & Welfare, Korea; Semyung University
• Investigators: Principal Investigator: Kap-Sung Kim, Ph.D., Donnguk University Oriental Medical center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (Estimate): April 3, 2012

Study Record Updates

• Last Update Posted (Estimate): April 4, 2012
• Last Update Submitted That Met QC Criteria: April 2, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: acupuncture; Knee osteoarthritis; sham acupuncture
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: B080017-KCT0000385