NCT00272532

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
Last Updated

February 20, 2008

Status Verified

February 1, 2008

First QC Date

January 4, 2006

Last Update Submit

February 18, 2008

Conditions

Myofascial Pain Syndromes

Outcome Measures

Primary Outcomes (1)

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

Interventions

ThiocolchicosideDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

thiocolchicoside

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Edibe Taylan

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 6, 2006

Study Start

April 1, 2005

Last Updated

February 20, 2008

Record last verified: 2008-02

Locations

TU(1)