Back to resultsAcupuncture for Treatment of Chronic LBP, RCT, Single Blinded
Primary Purpose
Chronic Low Back Pain
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring acupuncture, RCTs, chronic LBP
Eligibility Criteria
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
Sites / Locations
- Wonkwang University Hospital
Outcomes
Primary Outcome Measures
Visual Analogue Scale, RDQ scale
Secondary Outcome Measures
Patient Global Assessment
Full Information
NCT ID
NCT00353847
First Posted
July 18, 2006
Last Updated
November 15, 2006
Sponsor
Korea Institute of Oriental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00353847
Brief Title
Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Korea Institute of Oriental Medicine
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of chronic LBP.
Detailed Description
The purpose of this study is as follows:
pain : VAS
Function : Roland Disability Scale
Side effect
Validity
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
acupuncture, RCTs, chronic LBP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
Visual Analogue Scale, RDQ scale
Secondary Outcome Measure Information:
Title
Patient Global Assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngdal Kwon, MD, Ph.D
Organizational Affiliation
Professor of College of Oriental Medicine, Wonkwang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonkwang University Hospital
City
Gwangju
ZIP/Postal Code
503-310
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded
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