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Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Korea Institute of Oriental Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT00353847
First received: July 18, 2006
Last updated: November 15, 2006
Last verified: June 2006
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013