Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Low Back Pain Patients: Randomized, Double-blind, Controlled Study
1 other identifier
interventional
276
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 low-back-pain
Started Oct 2010
Typical duration for phase_2 low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 26, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 6, 2012
April 1, 2012
1.8 years
March 26, 2012
April 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
Visual analog scale (VAS) is a tool used to measure pain. The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment and after the 6 week trearment period.
at baseline and after 6 weeks of treatment.
Secondary Outcomes (3)
Roland - Morris Disability Questionnaire
at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
SF-36
at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
Adverse Events
at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
Study Arms (4)
Individualized Acupuncture
EXPERIMENTALThe 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.
Standardized Acupuncture
EXPERIMENTALThe 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.
Sham acupuncture
SHAM COMPARATORNon-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.
Waiting
NO INTERVENTIONNo interventions were applied to the patients in this group. Only assessments were made at each visit.
Interventions
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
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.
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.
No interventions were applied to the patients in this group.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dongwoo Namlead
- Ministry of Health & Welfare, Koreacollaborator
- Gachon University Gil Medical Centercollaborator
Study Sites (1)
Kyung Hee University Oriental Medicine Hospital
Seoul, Seoul, 130-872, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jae-Dong Lee, Ph.D
Kyunghee University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 26, 2012
First Posted
April 4, 2012
Study Start
October 1, 2010
Primary Completion
August 1, 2012
Study Completion
December 1, 2012
Last Updated
April 6, 2012
Record last verified: 2012-04