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

NCT00690625 | Completed Phase 1

• 1 other identifier: 07-9505-B 01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofacial Pain

Keywords

Myofacial pain; Omega 3 fatty acids

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the score on the Characteristic Pain Intensity (CPI) scale is 0-10, ordinal.

  one month

Secondary Outcomes (1)

• Secondary outcome measure is satisfaction with the cream, Pain medicine use,

  One month

Study Arms (2)

A

EXPERIMENTAL

MyoRx cream

Drug: MyoRx Cream (6% Omega 3 Fatty Acid)

B

PLACEBO COMPARATOR

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

Drug: Placebo cream, no Omega 3 fatty acid

Interventions

MyoRx Cream (6% Omega 3 Fatty Acid) DRUG

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

A

Placebo cream, no Omega 3 fatty acid DRUG

Placebo cream, no Omega 3 fatty acid

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington, Medical center, Department of Oral Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Facial Pain

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ashwini V Khante, DDS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 9, 2008

Record last verified: 2008-12

Locations

US (1)