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临床试验/NCT04019093
NCT04019093已完成不适用

Acute Effects of Alcohol Use on Chronic Orofacial Pain

University of Florida1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年11月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Pressure Pain Intensity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Jaw pain patients

Experimental

Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).

干预措施: Ethanol (Drug)

Jaw pain patients

Experimental

Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).

干预措施: Placebo (Other)

Healthy controls

Experimental

Healthy social drinkers without jaw pain recruited as a comparison group.

干预措施: Ethanol (Drug)

Healthy controls

Experimental

Healthy social drinkers without jaw pain recruited as a comparison group.

干预措施: Placebo (Other)

结局指标

主要结局

Pressure Pain Intensity

时间窗: 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.

Pressure Pain Threshold

时间窗: 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.

Perceived Relief

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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