- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00272532
EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes
February 18, 2008 updated by: Sanofi
The Efficacy of Topical Thiocolchicoside in Cervical Myofascial Pain Syndrome: Triple-Arm, Single-Blind, Randomized, Prospective, Phase IV Clinical Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
65
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Registration Dates
First Submitted
January 4, 2006
First Submitted That Met QC Criteria
January 4, 2006
First Posted (Estimate)
January 6, 2006
Study Record Updates
Last Update Posted (Estimate)
February 20, 2008
Last Update Submitted That Met QC Criteria
February 18, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L_9892
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myofascial Pain Syndromes
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Bozyaka Training and Research HospitalEnrolling by invitationMyofascial Pain | Trigger Point Pain, Myofascial | Myofascial Trigger Point PainTurkey
-
Washington University School of MedicineRecruitingMyofascial Pain | Pelvic Pain | Pelvic Floor Myofascial PainUnited States
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University of ArizonaEnrolling by invitationMyofascial Pain | Myofascial Trigger Point PainUnited States
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Universidad Complutense de MadridCompletedMyofascial Pain | Trigger Point Pain, MyofascialSpain
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Quiropraxia y EquilibrioUniversidad Nacional Andres BelloCompletedMyofascial Trigger Point Pain (MTrP)Chile
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Indonesia UniversityCompletedMyofascial Pain of Upper Trapezius MuscleIndonesia
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Washington University School of MedicineNational Center for Complementary and Integrative Health (NCCIH)Recruiting
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Lithuanian University of Health SciencesCompleted
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Quiropraxia y EquilibrioNot yet recruitingMyofascial Trigger Point Pain (MTrP)Chile
Clinical Trials on Thiocolchicoside
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SanofiCompleted
-
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Yuzuncu Yıl UniversityCompletedQuality of Life | OcclusionTurkey
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Medipol UniversityCompleted
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Yuzuncu Yıl UniversityCompletedTemporomandibular DisorderTurkey
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Polyclinique de l'EuropeNot yet recruiting