Temporomandibular Joint Disorders
Conditions
Keywords
alcohol effects
Brief summary
Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.
Interventions
DRUGEthanol
A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
OTHERPlacebo
A beverage that does not meaningfully increase breath alcohol concentration.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
People with and without jaw pain, including temporomandibular joint and muscle disorder (TMD) will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Positive diagnosis of jaw pain, including temporomandibular joint and muscle disorder (TMD) (jaw pain group only) * Consume at least 1 drink/month over the past 6 months
Exclusion criteria
* History of chronic pain other than jaw pain or TMD * Current use of opioids * Current major depression * History of any psychotic disorder * Undercontrolled hypertension or diabetes * History of neurologic disease * History of serious medical illness * History of drug or alcohol dependence, including nicotine, or a pattern of hazardous alcohol use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Relief | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 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. |
| Pressure Pain Threshold | 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. |
| Pressure Pain Intensity | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Jaw Pain Patients 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. | 19 |
| Healthy Controls 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. | 29 |
| Total | 48 |
Baseline characteristics
| Characteristic | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| Age, Continuous | 26.74 years STANDARD_DEVIATION 5 | 25.72 years STANDARD_DEVIATION 4.12 | 26.13 years STANDARD_DEVIATION 4.47 |
| Alcohol Use Disorders Identification Test (total score) | 4.37 units on a scale STANDARD_DEVIATION 1.77 | 4.31 units on a scale STANDARD_DEVIATION 1.67 | 4.33 units on a scale STANDARD_DEVIATION 1.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 9 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 20 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Max Quantity (oz. abs. EtOH) | 4.29 oz. absolute ethanol STANDARD_DEVIATION 2.01 | 3.74 oz. absolute ethanol STANDARD_DEVIATION 1.41 | 3.96 oz. absolute ethanol STANDARD_DEVIATION 1.67 |
| Oral Health Impact Profile - TMDs (total score) | 31.79 units on a scale STANDARD_DEVIATION 14.74 | 10.14 units on a scale STANDARD_DEVIATION 11.26 | 18.71 units on a scale STANDARD_DEVIATION 16.53 |
| Quantity-Frequency Index | .426 oz. absolute ethanol consumed per day STANDARD_DEVIATION 0.35 | .551 oz. absolute ethanol consumed per day STANDARD_DEVIATION 0.39 | .48 oz. absolute ethanol consumed per day STANDARD_DEVIATION 0.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 17 Participants | 29 Participants |
| Region of Enrollment United States | 19 participants | 29 participants | 48 participants |
| Sex: Female, Male Female | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Male | 2 Participants | 10 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 29 | 0 / 19 | 0 / 29 |
| other Total, other adverse events | 0 / 19 | 1 / 29 | 0 / 19 | 0 / 29 |
| serious Total, serious adverse events | 0 / 19 | 0 / 29 | 0 / 19 | 0 / 29 |
Outcome results
Primary
Perceived Relief
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jaw Pain Patients: Ethanol | Perceived Relief | 40.58 VAS units | Standard Deviation 31.31 |
| Healthy Controls: Ethanol | Perceived Relief | 39.79 VAS units | Standard Deviation 30.58 |
| Jaw Pain Patients: Placebo | Perceived Relief | 7.91 VAS units | Standard Deviation 13.71 |
| Healthy Controls: Placebo | Perceived Relief | 5.51 VAS units | Standard Deviation 11.36 |
| Jaw Pain Patients: Ethanol, 5lbf | Perceived Relief | 41.00 VAS units | Standard Deviation 28.27 |
| Healthy Controls: Ethanol, 5lbf | Perceived Relief | 42.75 VAS units | Standard Deviation 30.14 |
| Jaw Pain Patients: Placebo, 5lbf | Perceived Relief | 7.20 VAS units | Standard Deviation 13.01 |
| Healthy Controls: Placebo, 5lbf | Perceived Relief | 5.57 VAS units | Standard Deviation 11.13 |
| Jaw Pain Patients: Ethanol, 6lbf | Perceived Relief | 39.72 VAS units | Standard Deviation 30.05 |
| Healthy Controls: Ethanol, 6lbf | Perceived Relief | 43.65 VAS units | Standard Deviation 29.61 |
| Jaw Pain Patients: Placebo, 6lbf | Perceived Relief | 7.20 VAS units | Standard Deviation 13.41 |
| Healthy Controls: Placebo, 6lbf | Perceived Relief | 5.89 VAS units | Standard Deviation 13.11 |
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level X group interaction.p-value: 0.5ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level interaction.p-value: 0.21ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the pressure level X group interaction.p-value: 0.053ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X group interaction.p-value: 0.98ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of pressure level.p-value: 0.71ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of group.p-value: 0.71ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of beverage condition.p-value: <0.0001ANOVA
Primary
Pressure Pain Intensity
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jaw Pain Patients: Ethanol | Pressure Pain Intensity | 23.96 VAS units | Standard Deviation 28.03 |
| Healthy Controls: Ethanol | Pressure Pain Intensity | 12.76 VAS units | Standard Deviation 13.44 |
| Jaw Pain Patients: Placebo | Pressure Pain Intensity | 32.39 VAS units | Standard Deviation 19.95 |
| Healthy Controls: Placebo | Pressure Pain Intensity | 22.05 VAS units | Standard Deviation 17.72 |
| Jaw Pain Patients: Ethanol, 5lbf | Pressure Pain Intensity | 35.43 VAS units | Standard Deviation 19.67 |
| Healthy Controls: Ethanol, 5lbf | Pressure Pain Intensity | 20.92 VAS units | Standard Deviation 17.02 |
| Jaw Pain Patients: Placebo, 5lbf | Pressure Pain Intensity | 41.81 VAS units | Standard Deviation 20.28 |
| Healthy Controls: Placebo, 5lbf | Pressure Pain Intensity | 29.98 VAS units | Standard Deviation 23.89 |
| Jaw Pain Patients: Ethanol, 6lbf | Pressure Pain Intensity | 37.19 VAS units | Standard Deviation 23.9 |
| Healthy Controls: Ethanol, 6lbf | Pressure Pain Intensity | 26.95 VAS units | Standard Deviation 23.06 |
| Jaw Pain Patients: Placebo, 6lbf | Pressure Pain Intensity | 46.10 VAS units | Standard Deviation 22.97 |
| Healthy Controls: Placebo, 6lbf | Pressure Pain Intensity | 34.03 VAS units | Standard Deviation 22.94 |
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X group interaction.p-value: 0.76ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X beverage condition interaction.p-value: 0.52ANCOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of beverage condition.p-value: 0.04ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of group.p-value: 0.017ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of pressure level.p-value: <0.0001ANOVA
Primary
Pressure Pain Threshold
Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.
Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jaw Pain Patients: Ethanol | Pressure Pain Threshold | 4.56 lbf | Standard Deviation 1.08 |
| Healthy Controls: Ethanol | Pressure Pain Threshold | 5.27 lbf | Standard Deviation 1.37 |
| Jaw Pain Patients: Placebo | Pressure Pain Threshold | 3.81 lbf | Standard Deviation 0.84 |
| Healthy Controls: Placebo | Pressure Pain Threshold | 4.51 lbf | Standard Deviation 1.21 |
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the beverage condition X group interaction.p-value: 0.99ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of beverage condition.p-value: <0.0001ANOVA
Comparison: 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of group.p-value: 0.015ANOVA