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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to verify the efficacy and safety of acupuncture treatments (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).

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Detailed Description

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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.

Conditions

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Osteoarthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Individualized Acupuncture

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Standardized Acupuncture

Intervention Type PROCEDURE

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

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.

Group Type SHAM_COMPARATOR

sham acupuncture

Intervention Type PROCEDURE

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

Waiting

No interventions were applied to the patients in this group. Only assessments were made at each visit.

Group Type NO_INTERVENTION

Waiting

Intervention Type OTHER

No interventions were applied to the patients in this group.

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Individualized Acupuncture

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

Intervention Type PROCEDURE

Waiting

No interventions were applied to the patients in this group.

Intervention Type OTHER

Other Intervention Names

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Park Sham Device No interventions

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No