EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00272532
Collaborator
(none)
65
1

Study Details

Study Description

Brief Summary

Study objective:
  • To demonstrate, in patients with myofascial pain syndrome in cervical region, the degree of efficacy of thiocolchicoside ointment administered to trigger point regions compared with the trigger point injection.
Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
The Efficacy of Topical Thiocolchicoside in Cervical Myofascial Pain Syndrome: Triple-Arm, Single-Blind, Randomized, Prospective, Phase IV Clinical Study
Study Start Date :
Apr 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Submitted to clinic with a complaint of head and neck pain

  • Be diagnosed as having myofascial pain syndrome by determining the active trigger points in trapezius and/or interscapular region according to criteria of Simons and Travel

  • Have 1 to 8 active trigger point(s)

Exclusion Criteria:
  • Have evident cervical discopathy and signs of osteoarthritis

  • Have bleeding diathesis or using anticoagulant medication which hinders injection

  • Have known malignity, being used steroids, have immunodepressive disorders and/or being taken immunodepressive drugs

  • Be pregnant or have the possibility of being pregnant or not being used a regular contraceptive method

  • Have known allergic reaction against Thiocolchicoside

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanofi-Aventis Istanbul Turkey

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Edibe Taylan, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00272532
Other Study ID Numbers:
  • L_9892
First Posted:
Jan 6, 2006
Last Update Posted:
Feb 20, 2008
Last Verified:
Feb 1, 2008
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 20, 2008