Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream

Completed · Phase 1 · Has a placebo group

Conditions studied: Myofacial Pain

In brief

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 Myofacial Pain. Omega-3 fatty acids have minimal side effects when applied topically. If Omega-3 fatty acids used in this study are shown to reduce myofacial pain then this formulation could potentially be used for treatment of TMD patents with myofacial pain in the future. Omega-3 fatty acids are natural ingredients with almost no side effects. Topical application can lead to fewer side effects than systemic medications. In addition, there is no substantial morbidity \& mortality associated with topical application of Omega-3 fatty acids. It is hypothesized that subjects receiving topical application of omega-3 fatty acids will demonstrate reduced subjective masseter muscle pain in comparison to subjects receiving placebo cream. This is a pilot study to assess the topical application of Omega-3 fatty acids on muscle pain in the muscles of mastication.

Key facts

Study ID

NCT00690625

Run by

University of Washington

People needed

40

Starts

2008-04-01

Expected to finish

2008-07-01

Last updated by the study team

2008-12-09

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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".

You may not qualify if…

• 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.

Where it is running

• University of Washington, Medical center, Department of Oral Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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