Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02295644
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 4
• Duration (Months): 11
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

Introduction. Temporomandibular disorders (TMD) are a group of conditions that are multifactorial in nature, and it primarily presents with symptoms of pain and decreased functional capacity. Therapeutic ultrasound is a method of physical therapy that has shown clinically to provide immediate relief of pain in patients with different musculoskeletal disorders. In this study, for the purpose of immediate management of painful masticatory muscle and tissues, the investigators attempt to understand the mechanism of therapeutic ultrasound by exploring the physiologic changes peripherally and centrally. In addition, the investigators aim to determine if there is a dose response relationship between two different intensities (0.4 W/cm2 and 0.8 W/cm2) and between two sets of duty cycles (50% and 100%). A third purpose is to determine if therapeutic ultrasound applied to the masseter muscle is capable of eliciting segmental effects in the temporalis muscle. Methods. A total of 28 adult females with bilateral myalgia according to Diagnostic criteria for TMD (DC/TMD) will be recruited for this investigational trial. Each subject will be randomly allocated to one of the four ultrasound intervention groups each of which has different settings. Using Sonicator®740, therapeutic ultrasound intervention will be performed on both masseters for five minutes on each side of the face. A template will be used to confine the borders of the muscle and to determine the sites for the repeated outcome measures. Outcome parameters of: self-reported pain scale, pressure pain threshold, electromyographic muscle amplitudes and intraoral muscle temperatures will be measured for masseter and temporalis muscles on each side of the face, and will be assessed at baseline and after intervention on each side.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Dysfunction Syndrome	Device: Ultrasound Sonicator 740	N/A

Detailed Description

The "Brief Summary" above encompasses the detailed description.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A: 0.4 Watts/Sq cm 50% Duty cycle 0.4 Watts/Sq cm 50% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 (MegaHertz) MHz, 5 minutes	Device: Ultrasound Sonicator 740; Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Experimental: B: 0.4 Watts/Sq cm 100% Duty cycle 0.4 Watts/Sq cm 100% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes	Device: Ultrasound Sonicator 740; Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Experimental: C: 0.8 Watts/Sq cm 50% Duty cycle 0.8 Watts/Sq cm 50% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes	Device: Ultrasound Sonicator 740; Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Experimental: D: 0.8 Watts/Sq cm 100% Duty cycle 0.8 Watts/Sq cm 100% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes	Device: Ultrasound Sonicator 740; Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes

Outcome Measures

Primary Outcome Measures

1. Self Report of Pain [Immediately before and after the intervention, difference used.]

   Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever

2. Pressure Pain Threshold of the Masseter Muscle [Immediately before and after the intervention, difference used.]

   Measuring pressure pain threshold using digital algometer

3. Intraoral Muscle Temperature [Immediately before and after the intervention, difference used.]

   Using digital thermometer on buccal mucosa, degrees celsius.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult females who have bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria and current pain intensity (≥4 out of 10, where 0 is no pain and 10 is the worst pain ever) on both sides.

Exclusion Criteria:

• Those who have a history or were diagnosed with systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).

• Certain conditions such as neoplasms or fractures.

• Neuropathies or neurological disorders.

• Participants who are currently taking muscle relaxants or analgesics.

• Those who have undergone any form of physical therapy within the last 60 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Dental Medicine	Buffalo	New York	United States	14214

Sponsors and Collaborators

• State University of New York at Buffalo

Investigators

• Principal Investigator: Willard McCall, State University of New York at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.D.McCall, Jr., Professor, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT02295644
• Other Study ID Numbers: SUNYBuffalo
• First Posted: Nov 20, 2014
• Last Update Posted: Jun 7, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by W.D.McCall, Jr., Professor, State University of New York at Buffalo: Therapeutic ultrasound
• Additional relevant MeSH terms: Joint Diseases; Myalgia; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Study Results

Participant Flow

Arm/Group Title	A (0.4W/Square Centimeter, 50%)	B (0.4W/Square Centimeter, 100%)	C (0.8W/Square Centimeter, 50%)	D (0.8W/Square Centimeter, 100%)
Arm/Group Description	0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.4 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Period Title: Overall Study
STARTED	7	7	7	7
COMPLETED	7	7	6	5
NOT COMPLETED	0	0	1	2

Baseline Characteristics

Arm/Group Title	A(0.4W/Square Centimeter, 50%)	B(0.4W/Square Centimeter, 100%)	C (0.8W/Square Centimeter, 50%)	D (0.8W/Square Centimeter, 100%)	Total
Arm/Group Description	0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.4 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	Total of all reporting groups
Overall Participants	7	7	6	5	25
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	7 100%	6 100%	5 100%	25 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	7 100%	7 100%	6 100%	5 100%	25 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	7 100%	6 100%	5 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Self Report of Pain
Description	Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever
Time Frame	Immediately before and after the intervention, difference used.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (0.4W/Square Centimeter, 50%)	B (0.4W/Square Centimeter, 100%)	C (0.8W/Square Centimeter, 50%)	D (0.8W/Square Centimeter, 100%)
Arm/Group Description	0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.4 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Measure Participants	7	7	6	5
Mean (Standard Deviation) [Scores on pain intensity scale]	-.86 (1.4)	-2.0 (.87)	-1.4 (1.1)	-1.3 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments	Interaction test of duty cycle and intensity for self reported pain score
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments	Main effect of duty cycle on self reported pain score.
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments	Main effect of intensity on self reported pain score.
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Pressure Pain Threshold of the Masseter Muscle
Description	Measuring pressure pain threshold using digital algometer
Time Frame	Immediately before and after the intervention, difference used.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (0.4W/Square Centimeter, 50%)	B (0.4W/Square Centimeter, 100%)	C (0.8W/Square Centimeter, 50%)	D (0.8W/Square Centimeter, 100%)
Arm/Group Description	0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.4 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Measure Participants	7	7	6	5
Mean (Standard Deviation) [Kpa/Cm^2]	-2.64 (31.79)	15.21 (5.75)	-5.12 (9.44)	-10.2 (12.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.24
	Comments	Main effect for duty cycle.
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments	Main effect for intensity.
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments	Interaction of intensity and duty cycle.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Intraoral Muscle Temperature
Description	Using digital thermometer on buccal mucosa, degrees celsius.
Time Frame	Immediately before and after the intervention, difference used.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A (0.4W/Square Centimeter, 50%)	B (0.4W/Square Centimeter, 100%)	C (0.8W/Square Centimeter, 50%)	D (0.8W/Square Centimeter, 100%)
Arm/Group Description	0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.4 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes	0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Measure Participants	7	7	6	5
Mean (Standard Deviation) [degrees Celsius, post minus pre]	.036 (.09)	.15 (.206)	.033 (.154)	.42 (.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments	Main effect for duty cycle.
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments	Main effect for intensity.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.475
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	A (0.4W/Square Centimeter, 50%), B (0.4W/Square Centimeter, 100%), C (0.8W/Square Centimeter, 50%), D (0.8W/Square Centimeter, 100%)
	Comments	Interaction of intensity and duty cycle.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.178
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	Throughout the trial of one hour.
Arm/Group Title	A(0.4W/Square Centimeter, 50%)		B(0.4W/Square Centimeter, 100%)		C(0.8W/Square Centimeter, 50%)		D (0.8W/Square Centimeter, 100%)
Arm/Group Description	0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes		0.4 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes		0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes		0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
All Cause Mortality
	A(0.4W/Square Centimeter, 50%)		B(0.4W/Square Centimeter, 100%)		C(0.8W/Square Centimeter, 50%)		D (0.8W/Square Centimeter, 100%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	A(0.4W/Square Centimeter, 50%)		B(0.4W/Square Centimeter, 100%)		C(0.8W/Square Centimeter, 50%)		D (0.8W/Square Centimeter, 100%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/6 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	A(0.4W/Square Centimeter, 50%)		B(0.4W/Square Centimeter, 100%)		C(0.8W/Square Centimeter, 50%)		D (0.8W/Square Centimeter, 100%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)		0/6 (0%)		0/5 (0%)

Limitations/Caveats

Three subjects who met the inclusion criteria on recruitment (bilateral masseter pain of four or more) did not meet the criteria at the time of the experiment so were not analyzed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.