Myofascial Pain SyndromesPhase 4NCT00272532
EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes
A Phase 4 study testing Thiocolchicoside in people with Myofascial Pain Syndromes, run by Sanofi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Thiocolchicoside
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2005to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Thiocolchicoside
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiocolchicosideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study startApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edibe Taylan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272532
- Sponsor's protocol ID
- L_9892
- Status last verified
- Feb 2008
- First submitted
- 4 Jan 2006
- Last updated
- 20 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Topical Thiocolchicoside in Cervical Myofascial Pain Syndrome: Triple-Arm, Single-Blind, Randomized, Prospective, Phase IV Clinical Study
- ClinicalTrials.gov ID
- NCT00272532
- Acronym / sponsor ID
- L_9892
- Conditions
- Myofascial Pain Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- First posted
- 6 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiocolchicoside | Drug | – |
Primary outcome
Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edibe Taylan study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thiocolchicoside in people with Myofascial Pain Syndromes, run by Sanofi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2008.