Trial Outcomes & Findings for Neurostimulation in Temporomandibular Disorders (TMD) Patients (NCT NCT01502709)
NCT ID: NCT01502709
Last Updated: 2016-04-26
Results Overview
The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.
TERMINATED
NA
5 participants
Daily Self-reports at Baseline and on Days 1 through 7
2016-04-26
Participant Flow
Participant milestones
| Measure |
Caloric Vestibular Neurostimulation
1 treatment of caloric vestibular neurostimulation for 7.5 minutes in the right ear
|
Placebo Arm
0 participants received placebo
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Caloric Vestibular Neurostimulation
1 treatment of caloric vestibular neurostimulation for 7.5 minutes in the right ear
|
Placebo Arm
0 participants received placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
Baseline Characteristics
Neurostimulation in Temporomandibular Disorders (TMD) Patients
Baseline characteristics by cohort
| Measure |
Caloric Vestibular Neurostimulation
n=5 Participants
1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
|
Placebo Arm
0 participants received placebo
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=93 Participants
|
—
|
0 participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 participants
n=93 Participants
|
—
|
5 participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=93 Participants
|
—
|
0 participants
n=27 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
—
|
48 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
|
Gender
Female
|
5 participants
n=93 Participants
|
—
|
5 participants
n=27 Participants
|
|
Gender
Male
|
0 participants
n=93 Participants
|
—
|
0 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
—
|
5 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Daily Self-reports at Baseline and on Days 1 through 7The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.
Outcome measures
| Measure |
Neurostimulator
n=1 Participants
1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
|
Placebo Arm
0 participants received placebo
|
|---|---|---|
|
Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment
|
30 millimeters
Standard Deviation NA
Data not analyzed because only complete information for 1 subject was available.
|
—
|
SECONDARY outcome
Timeframe: Days 1-7The mean of measures taken from days 1-7 was calculated. Composite pain is a measure of mean pain intensity experienced and pain duration. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. Duration of pain ranges from 0 to 100% of a day. For example a pain free subject would report O pain intensity for 0% of the day.
Outcome measures
| Measure |
Neurostimulator
n=1 Participants
1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
|
Placebo Arm
0 participants received placebo
|
|---|---|---|
|
Mean Percentage of Time Spent in Pain From Days 1-7
|
77 percentage of day in pain
Standard Deviation NA
Data not analyzed because only complete information for 1 subject was available.
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3RDC for Temporomandibular disorders (TMD) is a reliable \& valid system for diagnosis of TMD, utilizing clinical procedures, diagnostic algorithms, and a dual-axis assessment comprising symptom history and physical exam. Signs and symptoms were evaluated by a trained professional and the history was obtained through use of questionnaires. In all sections and scales the higher the number reported corresponds to the more pain being experienced, therefore, a worse outcome. The clinical exam consists of facial, dental, and cervical evaluations including mandibular range of motion, Temporomandibular disorders Joint sound, and palpation of the orofacial muscles and temporomandibular joints (TMJ). Subjects are classified as TMD if they report pain in or around the temporomandibular joints or muscles of mastication for more than 3 months.
Outcome measures
| Measure |
Neurostimulator
n=1 Participants
1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
|
Placebo Arm
0 participants received placebo
|
|---|---|---|
|
Number of Participants With Signs and Symptoms of Temporomandibular Disorder Based on Outcomes of Research Diagnostic Criteria (RDC) Exam
|
1 Participants
|
—
|
Adverse Events
Caloric Vestibular Neurostimulation
Placebo Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caloric Vestibular Neurostimulation
n=5 participants at risk
1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
|
Placebo Arm
0 participants received placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Facial flushing
|
20.0%
1/5 • Number of events 1 • 2 hours post-treatment
|
—
0/0 • 2 hours post-treatment
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • 2 hours post-treatment
|
—
0/0 • 2 hours post-treatment
|
|
General disorders
Dry Mouth
|
60.0%
3/5 • Number of events 3 • 2 hours post-treatment
|
—
0/0 • 2 hours post-treatment
|
|
General disorders
Feeling Cold
|
60.0%
3/5 • Number of events 3 • 2 hours post-treatment
|
—
0/0 • 2 hours post-treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place