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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
  Purpose

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


Condition Intervention
Chronic Neck Pain
 Procedure: acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Clinical Trial to Evaluate the Effect of East-West Collaborative Medicine on Chronic Cervical Pain: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyunghee University Medical Center:

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

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 45
Study Start Date: December 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • acupuncture
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
  • acupuncture
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
  • acupuncture

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

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205958

Contacts
Contact: Yu-Jeong Cho, OMD +82-2-440-7575 jamyunghwa@hotmail.com

Locations
Korea, Republic of
Kyunghee University East West Neo Medical Center Recruiting
Seoul, Korea, Republic of, 134-727
Contact: JaeHeung Cho, OMD     +82-2-440-7581     vetkong95@hanmail.net    
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Jun-Hwan Lee, OMD, PhD Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University
  More Information

No publications provided

Responsible Party: Jun-Hwan Lee / Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Kyung Hee University
ClinicalTrials.gov Identifier: NCT01205958     History of Changes
Other Study ID Numbers: KHU 20091458
Study First Received: September 14, 2010
Last Updated: September 20, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Kyunghee University Medical Center:
Cervical pain
Neck pain
western medicine
 oriental medicine
acupuncture
needle

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pyranoprofen
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
 Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013