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EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00272532
  Purpose

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 Intervention Phase
Myofascial Pain Syndromes
Drug: Thiocolchicoside
Phase IV

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Thiocolchicoside
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Efficacy of Topical Thiocolchicoside in Cervical Myofascial Pain Syndrome: Triple-Arm, Single-Blind, Randomized, Prospective, Phase IV Clinical Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction

Estimated Enrollment: 65
Study Start Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272532

Locations
Turkey
Sanofi-Aventis
Istanbul, Turkey
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Edibe Taylan Sanofi-Aventis
  More Information

clinicalstudyresults.org  This link exits the ClinicalTrials.gov site

Study ID Numbers: L_9892
Study First Received: January 4, 2006
Last Updated: February 18, 2008
ClinicalTrials.gov Identifier: NCT00272532  
Health Authority: Turkey: Ministry of Health

Study placed in the following topic categories:
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009