Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain

Dongwoo Nam

Status and phase: Unknown; Phase 2

Conditions: Low Back Pain

Treatments: Procedure: Individualized Acupuncture; Other: Waiting; Procedure: Sham Acupuncture; Procedure: Standardized Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01570127

KOMCIRB-02-20101130-02

Details and patient eligibility

About

The purpose of this study is to determine whether acupuncture treatment(Individualized & Standardized Acupuncture) is more effective than control (sham acupuncture or no treatment) and also whether individualized acupuncture is more effective than standardized acupuncture.

Full description

To determine whether individualized acupuncture is more effective than standardized acupuncture, 276 Low Back Pain patients will be recruited and randomly assigned to 4 separate groups.

Experimental groups(Individualized Acupuncture Group and Standardized Acupuncture Group) and Control groups (Sham acupuncture and waiting list)

The change of pain and physical functions will be compared among the four groups.

So the efficacy of acupuncture, and the best acupuncture treatment model will be determined. Also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.

Enrollment: 276 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients suffering Low Back Pain.
• Patients classified as Class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or Class 2(Low back pain with radiation of pain not beyond the knee, no neurological signs) according to the Quebec Task Force System
• Suffering pain which is more than 40mm on VAS(Visual Analog Scale)
• Voluntary participants who have completed the consent.

Exclusion criteria

• Low back trauma history within 6 months.
• Low back surgery history within 6 months.
• Low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation.
• Pain in other parts of the body more severe than low back pain.
• Mental problems that can influence the pain or results of questionnaire.
• Diseases that can interfere absorption, metabolism and excretion of medicine.
• History of alcohol or drug abuse within 12 months of the study.
• Pregnant, breastfeeding or childbearing aged women who are not using any birth control methods.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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276 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