Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded

November 15, 2006 updated by: Korea Institute of Oriental Medicine

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

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

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

The purpose of this study is as follows:

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

Study Type

Interventional

Enrollment

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visual Analogue Scale, RDQ scale

Secondary Outcome Measures

Outcome Measure
Patient Global Assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Youngdal Kwon, MD, Ph.D, Professor of College of Oriental Medicine, Wonkwang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 18, 2006

First Posted (Estimate)

July 19, 2006

Study Record Updates

Last Update Posted (Estimate)

November 16, 2006

Last Update Submitted That Met QC Criteria

November 15, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYD-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Low Back Pain

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