NCT01205958

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

September 14, 2010

Last Update Submit

September 20, 2010

Conditions

Keywords

Cervical painNeck painwestern medicineoriental medicineacupunctureneedle

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Visual Analogue Scale(VAS)

    7 week

Secondary Outcomes (4)

  • Neck disability index

    7 week

  • Beck depression inventory

    7 week

  • SF-36

    7 week

  • EQ-5D(EuroQol-5 dimension)

    7 week

Study Arms (3)

medication(Zaltoprofen)

ACTIVE COMPARATOR
Procedure: acupuncture

Acupuncture

ACTIVE COMPARATOR
Procedure: acupuncture

Zalprofen plus Acupuncture

ACTIVE COMPARATOR
Procedure: acupuncture

Interventions

acupuncturePROCEDURE

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

Also known as: Zaltoprofen
AcupunctureZalprofen plus Acupuncturemedication(Zaltoprofen)

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- presence of Chronic neck pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyunghee University East West Neo Medical Center

Seoul, 134-727, South Korea

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neck Pain

Interventions

Acupuncture Therapypyranoprofen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Jun-Hwan Lee, OMD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Jeong Cho, OMD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 21, 2010

Study Start

December 1, 2009

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations