Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Knee Osteoarthritis Patients: Randomized, Single-blind, Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Eun Jung Kim
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- WOMAC (Western Ontario and McMaster Universities) Scale change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •When researchers evaluate that it is not appropriate to participate in this clinical test
Arms & Interventions
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.
Intervention: Individualized Acupuncture (Procedure)
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.
Intervention: Standardized Acupuncture (Procedure)
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.
Intervention: sham acupuncture (Procedure)
Waiting
No interventions were applied to the patients in this group. Only assessments were made at each visit.
Intervention: Waiting (Other)
Outcomes
Primary Outcomes
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
WOMAC scale is checked by the patients. WOMAC scale is a tool to check of the disability, stiffness and pain by knee pain.
Secondary Outcomes
- 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)
- Adverse Events(at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit)
Investigators
Eun Jung Kim
Research professor
DongGuk University