EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Thiocolchicoside

About this trial

This is an interventional treatment trial for Myofascial Pain Syndromes

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction

Secondary Outcome Measures

Full Information

NCT ID

NCT00272532

First Posted

January 4, 2006

Last Updated

February 18, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00272532

Brief Title

EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myofascial Pain Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

65 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Thiocolchicoside

Primary Outcome Measure Information:

Title

Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edibe Taylan

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Istanbul

Country

Turkey

Myofascial Pain Syndromes

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial