Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatment acupuncture
Phase phase 3
Sponsor Korea Institute of Oriental Medicine
Start date July 2006
Trial size 50 participants
Trial identifier NCT00353847, KYD-06

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Visual Analogue Scale, RDQ scale
time frame:

Secondary Outcomes

Measure
Patient Global Assessment
time frame:

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Principal investigator Youngdal Kwon, MD, Ph.D
Description The purpose of this study is as follows: 1. pain : VAS 2. Function : Roland Disability Scale 3. Side effect 4. Validity
Trial information was received from ClinicalTrials.gov and was last updated in November 2006.
Information provided to ClinicalTrials.gov by Korea Institute of Oriental Medicine.