Status:
COMPLETED
Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream
Lead Sponsor:
University of Washington
Conditions:
Myofacial Pain
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate the effectiveness of topical application of omega-3 fatty acids (6% by volume) containing cream on persons with a TMD disorder, specifically with a diagnosis of Myof...
Detailed Description
The prevalence of clinically significant temporomandibular disorder (TMD)-related jaw pain has been estimated to be between 3% and 5%. Temporomandibular disorders (TMDs) are a group of conditions char...
Eligibility Criteria
Inclusion
- Subjects will be recruited who are ages 18 to 70 with a current diagnosis of myofacial pain (using RDC-TMD criteria) including pain on palpation of the masseter muscle. Subjects will be recruited from the Oral Medicine Clinic, School of Dentistry. Because this is a small pilot study, and there will not be sufficient sample size/power, only female subjects will be recruited, as temporomandibular disorder is more prevalent in women than men. Additional inclusion criteria include a "Characteristic Pain Intensity" (CPI) self reported score of three or more. This will be recorded on "Baseline Questionnaire".
Exclusion
- Study exclusion criteria:
- Males
- History of the trauma in last six months
- Other chronic pain conditions such as physician diagnosis of fibromyalgia, rheumatoid arthritis, etc
- Diagnosis of the disc displacement without reduction with limited opening of TMJ
- Age (less than 18 and more than 70)
- Evidence of complicating psychological or physical conditions which would prevent the subject from understanding/ participating in the study protocol
- Temporomandibular joint surgery on the affected side
- Allergy to any of the ingredients in the placebo and the active cream.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00690625
Start Date
April 1 2008
End Date
July 1 2008
Last Update
December 9 2008
Active Locations (1)
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1
University of Washington, Medical center, Department of Oral Medicine
Seattle, Washington, United States, 98195