Trial Outcomes & Findings for Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial (NCT NCT02295644)
NCT ID: NCT02295644
Last Updated: 2018-06-07
Results Overview
Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Immediately before and after the intervention, difference used.
Results posted on
2018-06-07
Participant Flow
Participant milestones
| Measure |
A (0.4W/Square Centimeter, 50%)
0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
B (0.4W/Square Centimeter, 100%)
0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
C (0.8W/Square Centimeter, 50%)
0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
D (0.8W/Square Centimeter, 100%)
0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
A (0.4W/Square Centimeter, 50%)
0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
B (0.4W/Square Centimeter, 100%)
0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
C (0.8W/Square Centimeter, 50%)
0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
D (0.8W/Square Centimeter, 100%)
0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
|---|---|---|---|---|
|
Overall Study
Did not meet inclusion criterion
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial
Baseline characteristics by cohort
| Measure |
A(0.4W/Square Centimeter, 50%)
n=7 Participants
0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
B(0.4W/Square Centimeter, 100%)
n=7 Participants
0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
C (0.8W/Square Centimeter, 50%)
n=6 Participants
0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
D (0.8W/Square Centimeter, 100%)
n=5 Participants
0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
25 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
A (0.4W/Square Centimeter, 50%)
n=7 Participants
0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
B (0.4W/Square Centimeter, 100%)
n=7 Participants
0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
C (0.8W/Square Centimeter, 50%)
n=6 Participants
0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
D (0.8W/Square Centimeter, 100%)
n=5 Participants
0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
|---|---|---|---|---|
|
Self Report of Pain
|
-.86 Scores on pain intensity scale
Standard Deviation 1.4
|
-2.0 Scores on pain intensity scale
Standard Deviation .87
|
-1.4 Scores on pain intensity scale
Standard Deviation 1.1
|
-1.3 Scores on pain intensity scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Immediately before and after the intervention, difference used.Measuring pressure pain threshold using digital algometer
Outcome measures
| Measure |
A (0.4W/Square Centimeter, 50%)
n=7 Participants
0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
B (0.4W/Square Centimeter, 100%)
n=7 Participants
0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
C (0.8W/Square Centimeter, 50%)
n=6 Participants
0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
D (0.8W/Square Centimeter, 100%)
n=5 Participants
0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
|---|---|---|---|---|
|
Pressure Pain Threshold of the Masseter Muscle
|
-2.64 Kpa/Cm^2
Standard Deviation 31.79
|
15.21 Kpa/Cm^2
Standard Deviation 5.75
|
-5.12 Kpa/Cm^2
Standard Deviation 9.44
|
-10.2 Kpa/Cm^2
Standard Deviation 12.04
|
PRIMARY outcome
Timeframe: Immediately before and after the intervention, difference used.Using digital thermometer on buccal mucosa, degrees celsius.
Outcome measures
| Measure |
A (0.4W/Square Centimeter, 50%)
n=7 Participants
0.4 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
B (0.4W/Square Centimeter, 100%)
n=7 Participants
0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
C (0.8W/Square Centimeter, 50%)
n=6 Participants
0.8 Watts/Sq cm 50% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
D (0.8W/Square Centimeter, 100%)
n=5 Participants
0.8 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
|
|---|---|---|---|---|
|
Intraoral Muscle Temperature
|
.036 degrees Celsius, post minus pre
Standard Deviation .09
|
.15 degrees Celsius, post minus pre
Standard Deviation .206
|
.033 degrees Celsius, post minus pre
Standard Deviation .154
|
.42 degrees Celsius, post minus pre
Standard Deviation .40
|
Adverse Events
A(0.4W/Square Centimeter, 50%)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B(0.4W/Square Centimeter, 100%)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C(0.8W/Square Centimeter, 50%)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D (0.8W/Square Centimeter, 100%)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Willard D McCall
University at Buffalo, School of Dental Medicine, Oral Diagnostic Sciences
Phone: (716)829-3559
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place