Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
NCT ID: NCT01570127
Last Updated: 2012-04-06
Study Results
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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UNKNOWN
PHASE2
276 participants
INTERVENTIONAL
2010-10-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Individualized Acupuncture
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.
Standardized Acupuncture
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) 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.
Sham Acupuncture
The treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral). Each session was 20 minutes long.
Waiting
No interventions were applied to the patients in this group. Only assessments were made at each visit.
Waiting
No interventions were applied to the patients in this group.
Interventions
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Individualized Acupuncture
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
Standardized Acupuncture
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) 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
The treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral). Each session was 20 minutes long.
Waiting
No interventions were applied to the patients in this group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Gachon University Gil Medical Center
OTHER
Dongwoo Nam
OTHER
Responsible Party
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Dongwoo Nam
Assistant Professor
Principal Investigators
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Jae-Dong Lee, Ph.D
Role: STUDY_CHAIR
Kyunghee University Medical Center
Locations
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Kyung Hee University Oriental Medicine Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KOMCIRB-02-20101130-02
Identifier Type: -
Identifier Source: org_study_id
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