Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream
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|ClinicalTrials.gov Identifier: NCT00690625|
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : December 9, 2008
|Condition or disease||Intervention/treatment||Phase|
|Myofacial Pain||Drug: MyoRx Cream (6% Omega 3 Fatty Acid) Drug: Placebo cream, no Omega 3 fatty acid||Phase 1|
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 characterized by pain or dysfunction in the temporomandibular joint (TMJ), the articular disc and/or the muscles of mastication. TMD is typically classified into three major diagnostic categories, using RDC-TMD classification criteria these would include Myofacial pain (with or without limitation), Disc Displacements (with and without reduction, including with a limited opening,) and Arthralgia, Arthritis and Arthrosis. These pain problems are about twice as common in women as in men in the general population and even four times more common in women in patient populations. A wide range of treatment modalities have been used for the management of myofacial pain. Physical treatments include ultrasound therapy, appliance therapy, intramuscular and nerve root stimulation, anesthetic injection, botulinum toxin injection and dry needling of trigger points, physical therapy, acupuncture and spray and stretch. The major goal of these treatments is to relieve pain and tightness of the involved muscles. Omega-3 fatty acids or fish oil are a family of polyunsaturated fatty acids. Omega-3 fatty acids are powerful anti-inflammatories and lower proinflammatory cytokines. However to obtain any discernible beneficial effects, large doses of Omega-3 fatty acids are required. Thus, topically applied alternatives prove beneficial over systemic routes. Studies show the anti-inflammatory properties of the Omega-3 fatty acids.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream; Randomized Double Blind Clinical Trial|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Drug: MyoRx Cream (6% Omega 3 Fatty Acid)
1/2 teaspoon 3 times per day for 30 days.
Placebo Comparator: B
Placebo cream, same composition as experimental cream, without Omega 3 fatty acid
Drug: Placebo cream, no Omega 3 fatty acid
Placebo cream, no Omega 3 fatty acid
- The primary outcome measure is the score on the Characteristic Pain Intensity (CPI) scale is 0-10, ordinal. [ Time Frame: one month ]
- Secondary outcome measure is satisfaction with the cream, Pain medicine use, [ Time Frame: One month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690625
|United States, Washington|
|University of Washington, Medical center, Department of Oral Medicine|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Ashwini V Khante, DDS||University of Washington|