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
- 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