- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00353847
Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded
November 15, 2006 updated by: Korea Institute of Oriental Medicine
A Randomized, Single Blind, Controlled Clinical Trial to Evaluate the Pain Relief Efficacy, Functional Improvement and Safety of Acupuncture in Patients With Chronic Low Back Pain
The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of chronic LBP.
Study Overview
Detailed Description
The purpose of this study is as follows:
- pain : VAS
- Function : Roland Disability Scale
- Side effect
- Validity
Study Type
Interventional
Enrollment
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gwangju, Korea, Republic of, 503-310
- Wonkwang University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having chronic, non-specific, LBP of at least 3 months' duration over 20 years old.
- Back pain must be the chief complaint
- Having normal neurological test
- Having signature voluntarily an IRB-approved consent form at enrollment
Exclusion Criteria:
- Potential spinal disease (e.g. a spinal tumor, infection or fracture etc)
- Other diseases (e.g. bleeding disease, dementia,epilepsy, neurogenic disorder etc)
- Planned or got lumbar surgery
- The prior use of acupuncture within the past 6 months
- Inflammatory arthritis
- The current use of systematic corticosteroids, narcotics, anticoagulants, muscle relaxants
- The involvement in legal problem related to LBP
- Refusal to be randomized
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Visual Analogue Scale, RDQ scale
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Secondary Outcome Measures
Outcome Measure |
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Patient Global Assessment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Youngdal Kwon, MD, Ph.D, Professor of College of Oriental Medicine, Wonkwang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Study Registration Dates
First Submitted
July 18, 2006
First Submitted That Met QC Criteria
July 18, 2006
First Posted (Estimate)
July 19, 2006
Study Record Updates
Last Update Posted (Estimate)
November 16, 2006
Last Update Submitted That Met QC Criteria
November 15, 2006
Last Verified
June 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYD-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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