We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00272532
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : February 20, 2008
Sponsor:
Information provided by:

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
Myofascial Pain Syndromes Drug: Thiocolchicoside Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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 : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arms and Interventions


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272532


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

ClinicalTrials.gov Identifier: NCT00272532     History of Changes
Other Study ID Numbers: L_9892
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: February 20, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Syndrome
Myofascial Pain Syndromes
Fibromyalgia
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents