Trial Outcomes & Findings for Acute Effects of Alcohol Use on Chronic Orofacial Pain (NCT NCT04019093)
NCT ID: NCT04019093
Last Updated: 2023-07-27
Results Overview
Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
Jaw Pain Patients: Ethanol First, Then Placebo
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD), randomized to receive ethanol first, followed by placebo.
The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Healthy Controls: Ethanol First, Then Placebo
Healthy social drinkers without jaw pain recruited as a comparison group who received ethanol first, randomized to receive ethanol first, followed by placebo.
The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Jaw Pain Patients: Placebo First, Then Ethanol
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD), randomized to receive placebo first, followed by ethanol.
The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Healthy Controls: Placebo First, Then Ethanol
Healthy social drinkers without jaw pain recruited as a comparison group who received ethanol first, randomized to receive placebo first, followed by ethanol.
The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
16
|
10
|
13
|
|
Overall Study
COMPLETED
|
9
|
16
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Effects of Alcohol Use on Chronic Orofacial Pain
Baseline characteristics by cohort
| Measure |
Jaw Pain Patients
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Healthy Controls
n=29 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.74 years
STANDARD_DEVIATION 5 • n=5 Participants
|
25.72 years
STANDARD_DEVIATION 4.12 • n=7 Participants
|
26.13 years
STANDARD_DEVIATION 4.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
29 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Alcohol Use Disorders Identification Test (total score)
|
4.37 units on a scale
STANDARD_DEVIATION 1.77 • n=5 Participants
|
4.31 units on a scale
STANDARD_DEVIATION 1.67 • n=7 Participants
|
4.33 units on a scale
STANDARD_DEVIATION 1.69 • n=5 Participants
|
|
Quantity-Frequency Index
|
.426 oz. absolute ethanol consumed per day
STANDARD_DEVIATION .35 • n=5 Participants
|
.551 oz. absolute ethanol consumed per day
STANDARD_DEVIATION .39 • n=7 Participants
|
.48 oz. absolute ethanol consumed per day
STANDARD_DEVIATION .36 • n=5 Participants
|
|
Max Quantity (oz. abs. EtOH)
|
4.29 oz. absolute ethanol
STANDARD_DEVIATION 2.01 • n=5 Participants
|
3.74 oz. absolute ethanol
STANDARD_DEVIATION 1.41 • n=7 Participants
|
3.96 oz. absolute ethanol
STANDARD_DEVIATION 1.67 • n=5 Participants
|
|
Oral Health Impact Profile - TMDs (total score)
|
31.79 units on a scale
STANDARD_DEVIATION 14.74 • n=5 Participants
|
10.14 units on a scale
STANDARD_DEVIATION 11.26 • n=7 Participants
|
18.71 units on a scale
STANDARD_DEVIATION 16.53 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.
Outcome measures
| Measure |
Jaw Pain Patients: Ethanol
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
|
Healthy Controls: Ethanol
n=29 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Jaw Pain Patients: Placebo
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Healthy Controls: Placebo
n=29 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Jaw Pain Patients: Ethanol, 5lbf
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
5lbf: Pressure applied to masseter insertion
|
Healthy Controls: Ethanol, 5lbf
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Placebo, 5lbf
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Healthy Controls: Placebo, 5lbf
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Ethanol, 6lbf
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
6lbf: Pressure applied to masseter insertion
|
Healthy Controls: Ethanol, 6lbf
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Placebo, 6lbf
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
Healthy Controls: Placebo, 6lbf
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pressure Pain Threshold
|
4.56 lbf
Standard Deviation 1.08
|
5.27 lbf
Standard Deviation 1.37
|
3.81 lbf
Standard Deviation 0.84
|
4.51 lbf
Standard Deviation 1.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)Population: Participant ratings from stimuli that were not within 0.5 lbf of the target pressure were excluded from analyses. This resulted in exclusion of 3 participants' data from this analysis.
Pain ratings associated with 4, 5, or 6 pound-feet (lbf) of pressure applied to the insertion of the masseter. VAS (visual analogue scale) pain intensity ratings anchored from 0 ("no pain at all") to 100 ("most intense imaginable") were collected. Higher values represent higher pain intensity.
Outcome measures
| Measure |
Jaw Pain Patients: Ethanol
n=17 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
|
Healthy Controls: Ethanol
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Jaw Pain Patients: Placebo
n=17 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Healthy Controls: Placebo
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Jaw Pain Patients: Ethanol, 5lbf
n=17 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
5lbf: Pressure applied to masseter insertion
|
Healthy Controls: Ethanol, 5lbf
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Placebo, 5lbf
n=17 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Healthy Controls: Placebo, 5lbf
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Ethanol, 6lbf
n=17 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
6lbf: Pressure applied to masseter insertion
|
Healthy Controls: Ethanol, 6lbf
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Placebo, 6lbf
n=17 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
Healthy Controls: Placebo, 6lbf
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pressure Pain Intensity
|
23.96 VAS units
Standard Deviation 28.03
|
12.76 VAS units
Standard Deviation 13.44
|
32.39 VAS units
Standard Deviation 19.95
|
22.05 VAS units
Standard Deviation 17.72
|
35.43 VAS units
Standard Deviation 19.67
|
20.92 VAS units
Standard Deviation 17.02
|
41.81 VAS units
Standard Deviation 20.28
|
29.98 VAS units
Standard Deviation 23.89
|
37.19 VAS units
Standard Deviation 23.90
|
26.95 VAS units
Standard Deviation 23.06
|
46.10 VAS units
Standard Deviation 22.97
|
34.03 VAS units
Standard Deviation 22.94
|
PRIMARY outcome
Timeframe: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)Population: One participant had missing data on this measure, resulting from exclusion from analyses.
Ratings of relief from pain associated with consumption of the study beverage following application of 4, 5, or 6 lbf stimuli. VAS (visual analogue scale) assessing perceived relief anchored from 0 ("No relief at all") to 100 ("Most profound relief imaginable"). Higher values represent greater perceived relief.
Outcome measures
| Measure |
Jaw Pain Patients: Ethanol
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
|
Healthy Controls: Ethanol
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Jaw Pain Patients: Placebo
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Healthy Controls: Placebo
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Jaw Pain Patients: Ethanol, 5lbf
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
5lbf: Pressure applied to masseter insertion
|
Healthy Controls: Ethanol, 5lbf
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Placebo, 5lbf
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Healthy Controls: Placebo, 5lbf
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
5lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Ethanol, 6lbf
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
6lbf: Pressure applied to masseter insertion
|
Healthy Controls: Ethanol, 6lbf
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
Jaw Pain Patients: Placebo, 6lbf
n=19 Participants
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
Healthy Controls: Placebo, 6lbf
n=28 Participants
Healthy social drinkers without jaw pain recruited as a comparison group.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
6lbf: Pressure applied to masseter insertion
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Perceived Relief
|
40.58 VAS units
Standard Deviation 31.31
|
39.79 VAS units
Standard Deviation 30.58
|
7.91 VAS units
Standard Deviation 13.71
|
5.51 VAS units
Standard Deviation 11.36
|
41.00 VAS units
Standard Deviation 28.27
|
42.75 VAS units
Standard Deviation 30.14
|
7.20 VAS units
Standard Deviation 13.01
|
5.57 VAS units
Standard Deviation 11.13
|
39.72 VAS units
Standard Deviation 30.05
|
43.65 VAS units
Standard Deviation 29.61
|
7.20 VAS units
Standard Deviation 13.41
|
5.89 VAS units
Standard Deviation 13.11
|
Adverse Events
Jaw Pain Patients: Ethanol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls: Ethanol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Jaw Pain Patients: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Jaw Pain Patients: Ethanol
n=19 participants at risk
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Healthy Controls: Ethanol
n=29 participants at risk
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Jaw Pain Patients: Placebo
n=19 participants at risk
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
Healthy Controls: Placebo
n=29 participants at risk
Healthy social drinkers without jaw pain recruited as a comparison group.
Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea and vomiting
|
0.00%
0/19 • Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session)
|
3.4%
1/29 • Number of events 1 • Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session)
|
0.00%
0/19 • Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session)
|
0.00%
0/29 • Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place