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

Osteoarthritis Knee Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01569230
• Other study ID #: B080017-KCT0000385
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2012
• Last updated: April 2, 2012
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: DongGuk University
• Contact: Eun Jung Kim, Ph.D.
• Phone: +82-31-961-9116
• Email: hanijjung[@]naver.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee

Intervention

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

Other:
• Waiting
No interventions were applied to the patients in this group.

Locations

Country	Name	City	State
Korea, Republic of	Donnguk University Oriental Medical center	Goyang	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Eun Jung Kim	Ministry of Health & Welfare, Korea, Semyung University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes