search
Back to results

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

Primary Purpose

Chronic Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Neck Pain focused on measuring Cervical pain, Neck pain, western medicine, oriental medicine, acupuncture, needle

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyunghee University East West Neo Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

medication(Zaltoprofen)

Acupuncture

Zalprofen plus Acupuncture

Arm Description

Outcomes

Primary Outcome Measures

Pain Scores on the Visual Analogue Scale(VAS)

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2010
Last Updated
September 20, 2010
Sponsor
Kyunghee University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01205958
Brief Title
The Effect of East-West Collaborative Medicine on Chronic Cervical Pain
Official Title
Clinical Trial to Evaluate the Effect of East-West Collaborative Medicine on Chronic Cervical Pain: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
Cervical pain, Neck pain, western medicine, oriental medicine, acupuncture, needle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
medication(Zaltoprofen)
Arm Type
Active Comparator
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Title
Zalprofen plus Acupuncture
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
Zaltoprofen
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analogue Scale(VAS)
Time Frame
7 week
Secondary Outcome Measure Information:
Title
Neck disability index
Description
Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities
Time Frame
7 week
Title
Beck depression inventory
Description
Beck depression inventory : for assessing depression
Time Frame
7 week
Title
SF-36
Description
questionnaire for measuring health-related quality of life
Time Frame
7 week
Title
EQ-5D(EuroQol-5 dimension)
Description
questionnaire for measuring health-related quality of life
Time Frame
7 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Jeong Cho, OMD
Phone
+82-2-440-7575
Email
jamyunghwa@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Hwan Lee, OMD, PhD
Organizational Affiliation
Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyunghee University East West Neo Medical Center
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JaeHeung Cho, OMD
Phone
+82-2-440-7581
Email
vetkong95@hanmail.net

12. IPD Sharing Statement

Citations:
PubMed Identifier
24171895
Citation
Cho JH, Nam DH, Kim KT, Lee JH. Acupuncture with non-steroidal anti-inflammatory drugs (NSAIDs) versus acupuncture or NSAIDs alone for the treatment of chronic neck pain: an assessor-blinded randomised controlled pilot study. Acupunct Med. 2014 Feb;32(1):17-23. doi: 10.1136/acupmed-2013-010410. Epub 2013 Oct 30.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs