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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01205958
Other study ID # KHU 20091458
Secondary ID
Status Recruiting
Phase N/A
First received September 14, 2010
Last updated September 20, 2010
Start date December 2009
Est. completion date February 2011

Study information

Verified date September 2010
Source Kyunghee University Medical Center
Contact Yu-Jeong Cho, OMD
Phone +82-2-440-7575
Email jamyunghwa@hotmail.com
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date February 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 55 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Kyunghee University East West Neo Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Scores on the Visual Analogue Scale(VAS) 7 week No
Secondary Neck disability index Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities 7 week No
Secondary Beck depression inventory Beck depression inventory : for assessing depression 7 week No
Secondary SF-36 questionnaire for measuring health-related quality of life 7 week No
Secondary EQ-5D(EuroQol-5 dimension) questionnaire for measuring health-related quality of life 7 week No
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