Myofacial PainPhase 1NCT00690625
Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream
A Phase 1 study testing MyoRx Cream (6% Omega 3 Fatty Acid) in people with Myofacial Pain, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Myofacial Pain
- What is being tested?
- MyoRx Cream (6% Omega 3 Fatty Acid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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".
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Medical center, Department of Oral Medicine
Seattle, Washington, 98195
About this study
Official title: Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream; Randomized Double Blind Clinical Trial
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.
Read the 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
- Being tested
- MyoRx Cream (6% Omega 3 Fatty Acid), Placebo cream, no Omega 3 fatty acid
- Keywords
- Myofacial pain, Omega 3 fatty acids
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoRx Cream (6% Omega 3 Fatty Acid)Drug
1/2 teaspoon 3 times per day for 30 days.
Placebo cream, no Omega 3 fatty acidDrug
Placebo cream, no Omega 3 fatty acid
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | MyoRx cream Receives: Drug: MyoRx Cream (6% Omega 3 Fatty Acid) |
| B | Placebo comparator | Placebo cream, same composition as experimental cream, without Omega 3 fatty acid Receives: Drug: Placebo cream, no Omega 3 fatty acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the score on the Characteristic Pain Intensity (CPI) scale is 0-10, ordinal.
Measured: one month
Secondary outcomes (1)
Secondary outcome measure is satisfaction with the cream, Pain medicine use,
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Ashwini V Khante, DDS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690625
- Sponsor's protocol ID
- 07-9505-B 01
- Status last verified
- Dec 2008
- First submitted
- 2 Jun 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of MyoRx (Omega 3 Fatty Acids Containing) Cream; Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT00690625
- Acronym / sponsor ID
- 07-9505-B 01
- Conditions
- Myofacial Pain
- Keywords
- Myofacial pain, Omega 3 fatty acids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MyoRx Cream (6% Omega 3 Fatty Acid)MyoRx cream |
| B | Placebo comparator | Drug: Placebo cream, no Omega 3 fatty acidPlacebo cream, same composition as experimental cream, without Omega 3 fatty acid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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".
Key exclusion criteria (9 listed)
- Study exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyoRx Cream (6% Omega 3 Fatty Acid)1/2 teaspoon 3 times per day for 30 days. | Drug | A |
| Placebo cream, no Omega 3 fatty acidPlacebo cream, no Omega 3 fatty acid | Drug | B |
Primary outcome
The primary outcome measure is the score on the Characteristic Pain Intensity (CPI) scale is 0-10, ordinal.
Time frame: one month
1 secondary outcome
Secondary outcome measure is satisfaction with the cream, Pain medicine use,
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashwini V Khante, DDS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MyoRx Cream (6% Omega 3 Fatty Acid) in people with Myofacial Pain, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the score on the Characteristic Pain Intensity (CPI) scale is 0-10, ordinal. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2008.