NCT00353847UnknownPhase 3
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
Korea Institute of Oriental Medicine1 site in 1 country50 target enrollmentStarted: July 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale, RDQ scale
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Visual Analogue Scale, RDQ scale
Secondary Outcomes
- Patient Global Assessment
Investigators
Study Sites (1)
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