Clinical trial NCT01569230: Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis Knee
Keywords: Knee osteoarthritis
acupuncture
sham acupuncture
Lead sponsor: DongGuk University
Sponsor class: OTHER
Collaborators: name: Semyung University
name: Ministry of Health & Welfare, Korea
First posted: 2012-04-03
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities) Scale change
timeFrame: 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:
measure: 100mm Pain Visual Analogue Scale
timeFrame: 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
measure: 6 Minute walk test
timeFrame: 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
measure: WOMAC pain
timeFrame: 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
measure: Investigator global assessment(IGA)
timeFrame: 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
measure: Patient global assessment(PGA)
timeFrame: 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
measure: Adverse Events
timeFrame: at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Donnguk University Oriental Medical center
state: Gyeonggi-do
Study officials:
affiliation: Donnguk University Oriental Medical center
name: Kap-Sung Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.