Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream
Condition: Myofacial Pain
MeSH terms: Facial Pain
Study type: Interventional
Phase: Phase 1

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 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.
    

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 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.
    

Intervention name(s): MyoRx Cream (6% Omega 3 Fatty Acid); Placebo cream, no Omega 3 fatty acid
Intervention type(s): Drug; Drug
Intervention description(s): 1/2 teaspoon 3 times per day for 30 days.; Placebo cream, no Omega 3 fatty acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Myofacial pain; Omega 3 fatty acids