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
NCT number | NCT00272532 |
Other study ID # | L_9892 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | January 4, 2006 |
Last updated | February 18, 2008 |
Start date | April 2005 |
Verified date | February 2008 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Sanofi-Aventis | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Turkey,
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 |
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