The Effect of East-West Collaborative Medicine on Chronic Cervical Pain

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Kyunghee University Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Kyunghee University Medical Center

ClinicalTrials.gov Identifier:

NCT01205958

First received: September 14, 2010

Last updated: September 20, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2010

Last Updated Date

September 20, 2010

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain Scores on the Visual Analogue Scale(VAS) [ Time Frame: 7 week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01205958 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Neck disability index [ Time Frame: 7 week ] [ Designated as safety issue: No ]
Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities
Beck depression inventory [ Time Frame: 7 week ] [ Designated as safety issue: No ]
Beck depression inventory : for assessing depression
SF-36 [ Time Frame: 7 week ] [ Designated as safety issue: No ]
questionnaire for measuring health-related quality of life
EQ-5D(EuroQol-5 dimension) [ Time Frame: 7 week ] [ Designated as safety issue: No ]
questionnaire for measuring health-related quality of life

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of East-West Collaborative Medicine on Chronic Cervical Pain

Official Title ^ICMJE

Clinical Trial to Evaluate the Effect of East-West Collaborative Medicine on Chronic Cervical Pain: a Pilot Study

Brief Summary

The purpose of this study is to assess the effect of East-West collaborative medicine on chronic cervical pain.

Detailed Description

Design: This is a randomized, controlled study.

Participants: 45 participants with chronic cervical pain are recruited and randomly assigned to three groups.

Intervention: Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Chronic Neck Pain

Intervention ^ICMJE

Procedure: acupuncture

Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks

Other Names:

Zaltoprofen
acupuncture

Study Arm (s)

Active Comparator: medication(Zaltoprofen)
Intervention: Procedure: acupuncture
Active Comparator: Acupuncture
Intervention: Procedure: acupuncture
Active Comparator: Zalprofen plus Acupuncture
Intervention: Procedure: acupuncture

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2011

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

- presence of Chronic neck pain

Exclusion Criteria:

Cancer
Spinal infection
ankylosing spondylosis
myelopathy
moderate hypertension or more
serious mental disease
other skeletomuscular disease
history of operation or acupuncture treatment about spinal disease

Gender

Both

Ages

25 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yu-Jeong Cho, OMD

+82-2-440-7575

jamyunghwa@hotmail.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01205958

Other Study ID Numbers ^ICMJE

KHU 20091458

Has Data Monitoring Committee

Yes

Responsible Party

Jun-Hwan Lee / Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Kyung Hee University

Study Sponsor ^ICMJE

Kyunghee University Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jun-Hwan Lee, OMD, PhD

Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University

Information Provided By

Kyunghee University Medical Center

Verification Date

September 2010

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

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