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

September 20, 2010 updated by: Kyunghee University Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 134-727
        • Recruiting
        • Kyunghee University East West Neo Medical Center
        • Contact:

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

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acupuncture
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
Active Comparator: medication(Zaltoprofen)
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
Active Comparator: Zalprofen plus Acupuncture
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Scores on the Visual Analogue Scale(VAS)
Time Frame: 7 week
7 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck disability index
Time Frame: 7 week
Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities
7 week
Beck depression inventory
Time Frame: 7 week
Beck depression inventory : for assessing depression
7 week
SF-36
Time Frame: 7 week
questionnaire for measuring health-related quality of life
7 week
EQ-5D(EuroQol-5 dimension)
Time Frame: 7 week
questionnaire for measuring health-related quality of life
7 week

Collaborators and Investigators

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

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Jun-Hwan Lee, OMD, PhD, Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (Estimate)

September 21, 2010

Study Record Updates

Last Update Posted (Estimate)

September 21, 2010

Last Update Submitted That Met QC Criteria

September 20, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHU 20091458

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 Neck Pain

Clinical Trials on acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe