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

Tracking Information

First Received Date ^ICMJE

July 18, 2006

Last Updated Date

November 15, 2006

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Visual Analogue Scale, RDQ scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00353847 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patient Global Assessment

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Acupuncture for Treatment of Chronic LBP, RCT, Single Blinded

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Low Back Pain

Intervention ^ICMJE

Device: Acupuncture

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00353847

Other Study ID Numbers ^ICMJE

KYD-06

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Korea Institute of Oriental Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Youngdal Kwon, MD, Ph.D

Professor of College of Oriental Medicine, Wonkwang University

Information Provided By

Korea Institute of Oriental Medicine

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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