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

Eun Jung Kim

Status: Unknown

Conditions: Osteoarthritis Knee

Treatments: Procedure: Individualized Acupuncture; Other: Waiting; Procedure: Standardized Acupuncture; Procedure: sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01569230

B080017-KCT0000385

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 4 patient groups

Individualized acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Individualized Acupuncture

Standardized Acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Standardized Acupuncture

Sham acupuncture

Sham Comparator group

Description:

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.

Treatment:

Procedure: sham acupuncture

Waiting

No Intervention group

Description:

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

Treatment:

Other: Waiting