EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes

Myofascial Pain Syndromes Clinical Trial

Official title:

The Efficacy of Topical Thiocolchicoside in Cervical Myofascial Pain Syndrome: Triple-Arm, Single-Blind, Randomized, Prospective, Phase IV Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272532
• Other study ID #: L_9892
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2006
• Last updated: February 18, 2008
• Start date: April 2005

Study information

• Verified date: February 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Syndrome

Intervention

Drug:
• Thiocolchicoside

Locations

Country	Name	City	State
Turkey	Sanofi-Aventis	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction