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

Primary Purpose

Myofacial Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MyoRx Cream (6% Omega 3 Fatty Acid)
Placebo cream, no Omega 3 fatty acid
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofacial Pain focused on measuring Myofacial pain, Omega 3 fatty acids

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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".

Exclusion Criteria:

  • Study 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.

Sites / Locations

  • University of Washington, Medical center, Department of Oral Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

MyoRx cream

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2008
Last Updated
December 8, 2008
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00690625
Brief Title
Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream
Official Title
Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream; Randomized Double Blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofacial Pain
Keywords
Myofacial pain, Omega 3 fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
MyoRx cream
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo cream, same composition as experimental cream, without Omega 3 fatty acid
Intervention Type
Drug
Intervention Name(s)
MyoRx Cream (6% Omega 3 Fatty Acid)
Intervention Description
1/2 teaspoon 3 times per day for 30 days.
Intervention Type
Drug
Intervention Name(s)
Placebo cream, no Omega 3 fatty acid
Intervention Description
Placebo cream, no Omega 3 fatty acid
Primary Outcome Measure Information:
Title
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 Information:
Title
Secondary outcome measure is satisfaction with the cream, Pain medicine use,
Time Frame
One month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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". Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwini V Khante, DDS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington, Medical center, Department of Oral Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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

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