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

NCT ID: NCT00690625

Last Updated: 2008-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-07-31

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 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.

Conditions

Myofacial Pain

Keywords

Myofacial pain; Omega 3 fatty acids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

MyoRx cream

Group Type: EXPERIMENTAL

MyoRx Cream (6% Omega 3 Fatty Acid)

Intervention Type: DRUG

1/2 teaspoon 3 times per day for 30 days.

B

Placebo cream, same composition as experimental cream, without Omega 3 fatty acid

Group Type: PLACEBO_COMPARATOR

Placebo cream, no Omega 3 fatty acid

Intervention Type: DRUG

Placebo cream, no Omega 3 fatty acid

Interventions

MyoRx Cream (6% Omega 3 Fatty Acid)

1/2 teaspoon 3 times per day for 30 days.

Intervention Type: DRUG

Placebo cream, no Omega 3 fatty acid

Placebo cream, no Omega 3 fatty acid

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. Males

2. History of the trauma in last six months

3. Other chronic pain conditions such as physician diagnosis of fibromyalgia, rheumatoid arthritis, etc

4. Diagnosis of the disc displacement without reduction with limited opening of TMJ

5. Age (less than 18 and more than 70)

6. Evidence of complicating psychological or physical conditions which would prevent the subject from understanding/ participating in the study protocol

7. Temporomandibular joint surgery on the affected side

8. Allergy to any of the ingredients in the placebo and the active cream.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University Of Washington

Principal Investigators

Ashwini V Khante, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington, Medical center, Department of Oral Medicine

Seattle, Washington, United States

Countries

United States

Other Identifiers

07-9505-B 01

Identifier Type: -

Identifier Source: org_study_id