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Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded
This study is ongoing, but not recruiting participants.
Sponsored by: Korea Institute of Oriental Medicine
Information provided by: Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00353847
  Purpose

The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of chronic LBP.


Condition Intervention Phase
Chronic Low Back Pain
Device: Acupuncture
Phase III

MedlinePlus related topics: Acupuncture Back Pain
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Korea Institute of Oriental Medicine:

Primary Outcome Measures:
  • Visual Analogue Scale, RDQ scale

Secondary Outcome Measures:
  • Patient Global Assessment

Estimated Enrollment: 50
Study Start Date: July 2006
Detailed Description:

The purpose of this study is as follows:

  1. pain : VAS
  2. Function : Roland Disability Scale
  3. Side effect
  4. Validity
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353847

Locations
Korea, Republic of
Wonkwang University Hospital
Gwangju, Korea, Republic of, 503-310
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Investigators
Principal Investigator: Youngdal Kwon, MD, Ph.D Professor of College of Oriental Medicine, Wonkwang University
  More Information

Study ID Numbers: KYD-06
Study First Received: July 18, 2006
Last Updated: November 15, 2006
ClinicalTrials.gov Identifier: NCT00353847  
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Institute of Oriental Medicine:
acupuncture, RCTs, chronic LBP

Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009