Adult FemalesNCT04086862
Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz
A study testing Therapeutic ultrasound in people with Adult Females and Bilateral Masseter Myalgia, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Temporomandibular disorders (TMD) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. These disorders are characterized by regional pain and limitation of mandibular range of motion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adult Females, Bilateral Masseter Myalgia
- What is being tested?
- Therapeutic ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 20 Mar 2021
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females
- Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria
- An average pain of 5 or more on a 0 to 10 scale over the last 30 days.
Who cannot join
- A history or diagnosis of systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).
- Certain conditions such as neoplasms or fractures.
- Neuropathies or neurological disorders.
- Currently taking muscle relaxants or analgesics.
- Undergone any form of physical therapy within the last 60 days.
- Severe bruxism requiring mouth-guard treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Temporomandibular disorders (TMD) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. These disorders are characterized by regional pain and limitation of mandibular range of motion. Pain-related TMD affects approximately 5% to 12% of the population and can affect individual's quality of life. The incidence is about 4 percent. Therapeutic ultrasound is a type of physical therapy that delivers energy via propagation of ultrasonic waves. One gap in knowledge is whether 1 megahertz (MHz) treating frequency has the same efficacy as treating with 3 MHz. This research proposes to test that.
Read the detailed description
See brief summary.
- Conditions
- Adult Females, Bilateral Masseter Myalgia
- Being tested
- Therapeutic ultrasound
- Keywords
- temporomandibular disorders, masseter myalgia, adult female
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ultrasoundProcedure or surgery
A commercially available ultrasound machine will provide 5 minutes of ultrasound at 0.4 watt/cm^2 and 100% duty cycle sequentially to each masseter muscle.
| Study group | Role | What they receive |
|---|---|---|
| The 1 MHz group | Active comparator | The 1 MHz group will receive therapeutic ultrasound at the 1 MHz setting. Receives: Procedure: Therapeutic ultrasound |
| The 3 MHz group | Experimental | The 3 MHz group will receive therapeutic ultrasound at the 3 MHz setting. Receives: Procedure: Therapeutic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in masseter pain by visual analog pain scale.
Reduction in masseter pain as measured on a visual analog scale (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable).
Measured: Baseline to fifth week.
Reduction in masseter pain by pressure pain threshold.
Reduction in masseter pain as measured with the pressure pain threshold (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable)..
Measured: Baseline to fifth week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start24 Oct 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult FemalesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to double-blind treatment with 1 MHz or 3 MHz therapeutic ultrasound.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W.D.McCall, Jr., State University of New York at Buffalo
- Investigators
- W. D. McCall, Ph.D., Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086862
- Sponsor's protocol ID
- Study00001683
- Status last verified
- Apr 2022
- First submitted
- 10 Sep 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be shared after analysis completed.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz
- ClinicalTrials.gov ID
- NCT04086862
- Acronym / sponsor ID
- Study00001683
- Conditions
- Adult Females, Bilateral Masseter Myalgia
- Keywords
- temporomandibular disorders, masseter myalgia, adult female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 12 Sep 2019 (actual)
- 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.
Temporomandibular disorders (TMD) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. These disorders are characterized by regional pain and limitation of mandibular range of motion. Pain-related TMD affects approximately 5% to 12% of the population and can affect individual's quality of life. The incidence is about 4 percent. Therapeutic ultrasound is a type of physical therapy that delivers energy via propagation of ultrasonic waves. One gap in knowledge is whether 1 megahertz (MHz) treating frequency has the same efficacy as treating with 3 MHz. This research proposes to test that.
Detailed description
See brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Subjects will be randomized to double-blind treatment with 1 MHz or 3 MHz therapeutic ultrasound.
| Arm | Type | Receives |
|---|---|---|
| The 1 MHz group | Active comparator | Procedure: Therapeutic ultrasoundThe 1 MHz group will receive therapeutic ultrasound at the 1 MHz setting. |
| The 3 MHz group | Experimental | Procedure: Therapeutic ultrasoundThe 3 MHz group will receive therapeutic ultrasound at the 3 MHz setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult females
- Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria
- An average pain of 5 or more on a 0 to 10 scale over the last 30 days.
Key exclusion criteria (6 listed)
- A history or diagnosis of systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).
- Certain conditions such as neoplasms or fractures.
- Neuropathies or neurological disorders.
- Currently taking muscle relaxants or analgesics.
- Undergone any form of physical therapy within the last 60 days.
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 |
|---|---|---|
| Therapeutic ultrasoundA commercially available ultrasound machine will provide 5 minutes of ultrasound at 0.4 watt/cm^2 and 100% duty cycle sequentially to each masseter muscle. | Procedure or surgery | The 1 MHz group, The 3 MHz group |
Primary outcome
Reduction in masseter pain by visual analog pain scale.
Time frame: Baseline to fifth week.
Reduction in masseter pain as measured on a visual analog scale (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable).
Reduction in masseter pain by pressure pain threshold.
Time frame: Baseline to fifth week.
Reduction in masseter pain as measured with the pressure pain threshold (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable)..
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 7 Apr 2022.
- Individual participant dataSharing planned: No. De-identified data may be shared after analysis completed.
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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.
W. D. McCall, Ph.D. principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic ultrasound in people with Adult Females and Bilateral Masseter Myalgia, run by State University of New York at Buffalo 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 3 inclusion and 6 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 7 Apr 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Reduction in masseter pain by visual analog pain scale. (time frame: Baseline to fifth week.). The study lists 2 primary outcomes in all. 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 7 Apr 2022.