State of Hormones Impact Nociceptive Expression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Experimental Pain Sensitivity
研究概览
简要总结
The Investigators have recently published on differences in pain sensitivity measures between cis and trans individuals in the local area. The investigators observed the anticipated differences in pain sensitivity between CM and CW (CW > CM), but found that the TW were phenotypically similar to CW in all measures. However, the investigators did not assess hormone level, nor did the investigators recruit TM participants. Here, with the assistance of two local community group stakeholders the investigators will recruit the following groups: CM, CW, TM+T (currently taking exogenous testosterone), TW+E (exogenous estradiol), TM, and TW (n=20/group). The investigators will use quantitative sensory testing to assess sensitivity to cold, pressure, and heat via standardized protocols. Blood samples will be taken for assessment of stress and reproductive hormone levels, immune cell populations and stimulated cytokine release. Finally, questionnaires will measure pain state, quality of life (QOL), voice QOL, body image, appearance, self-reported health, masculinity/femininity, community connectedness, gender role, sleep, depression, social support, adverse childhood experiences and stigma.
详细描述
Aim 1: To determine the impact of gender identity, genetic sex and hormone status on pain sensitivity.
Hypotheses: CM, TM and TM+T will have higher thresholds and lower sensitivity across the majority of pain tests when compared to CW, TW, and TW+E. Gender identity will influence pain sensitivity.
Aim 2: To examine social and psychological factors that contribute to pain sensitivity in our groups.
Hypotheses: Trans individuals will have pain sensitivity scores that align with their identified gender and will not be related to hormone levels or genetic sex. Stress, sleep quality, depression, social support and perceived discrimination will affect pain sensitivity measures.
Aim 3: To quantify differences in immune cell populations and activity between our groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-identification as one of the above gender identities
- •understanding of verbal and written English.
- •participants that have been on/off hormone treatment for at least 6 months
排除标准
- •pain in at least 3/7 days/week for the past 3 months
- •HIV positive diagnosis
- •cardiovascular or pulmonary disease
- •regular use of opioid pain medications
- •uncontrolled hypertension (i.e. SBP/DBP of > 150/95)
- •current illness accompanied by fever (body temperature >38 °C)
- •prostatectomy, hysterectomy or oophorectomy
- •hospitalization due to psychiatric illness within the last 6 months.
研究组 & 干预措施
Transgender Woman
Person assigned male at birth and whose gender identity is woman.
干预措施: Quantative sensory testing (Behavioral)
Transgender Woman
Person assigned male at birth and whose gender identity is woman.
干预措施: Blood Draw (Diagnostic Test)
Transgender Man plus Testosterone
Person assigned female at birth and whose gender identity is man and are currently on testosterone replacement.
干预措施: Quantative sensory testing (Behavioral)
Transgender Man
Person assigned female at birth and whose gender identity is man.
干预措施: Blood Draw (Diagnostic Test)
Transgender Man plus Testosterone
Person assigned female at birth and whose gender identity is man and are currently on testosterone replacement.
干预措施: Blood Draw (Diagnostic Test)
Cis Man
Person assigned male at birth and whose gender identity is man.
干预措施: Blood Draw (Diagnostic Test)
Cis Man
Person assigned male at birth and whose gender identity is man.
干预措施: Quantative sensory testing (Behavioral)
Cis Woman
Person assigned female at birth and whose gender identity is woman.
干预措施: Quantative sensory testing (Behavioral)
Cis Woman
Person assigned female at birth and whose gender identity is woman.
干预措施: Blood Draw (Diagnostic Test)
Transgender Man
Person assigned female at birth and whose gender identity is man.
干预措施: Quantative sensory testing (Behavioral)
Transgender Woman plus Estrogen
Person assigned male at birth and whose gender identity is woman and are currently on estrogen replacement.
干预措施: Quantative sensory testing (Behavioral)
Transgender Woman plus Estrogen
Person assigned male at birth and whose gender identity is woman and are currently on estrogen replacement.
干预措施: Blood Draw (Diagnostic Test)
结局指标
主要结局
Experimental Pain Sensitivity
时间窗: Baseline
In the cold pressor task, temporal summation and conditioned pain modulation tasks, the participants will rate any painful sensations on a 0-100 scale. On this scale, 0 refers to "no pain" and 100 refers to "worst pain imaginable". The ratings will be the basis for determining pain sensitivity.
Conditioned Pain Modulation
时间窗: Baseline
The pressure pain threshold taken alone will be subtracted from the pressure pain threshold obtained while the hand is in cold water as a measure of CPM.
Experimental Pressure Pain Thresholds
时间窗: Baseline
Pressure pain thresholds will be assessed by algometer. The average kPa of force at which the participant detects the pressure as painful will be the threshold.
Immune cell cytokine production
时间窗: Baseline
Isolated immune cells (PBMCs) will be simulated and cytokine production measured. IL-4+, IL-17A+, IFNgamma+ cells will be measured as percent of total PBMCs.
Temporal Summation
时间窗: Baseline
Pain ratings on repeated stimulation with heat will be used to determine temporal summation by taking the differences in pain ratings between the fifth and first stimulation. Pain will be rated as 0 (no pain at all ) to 100 (worst pain imaginable).
Social Support
时间窗: Baseline
A social support survey will be given to measure the amount of social support experienced by each participant. Each item will be scored, giving a score from 0-100 with higher scores representing greater social support.
Hormone levels
时间窗: Baseline
Testosterone and estradiol will be assessed in blood samples.
Experimental Heat Pain Thresholds
时间窗: Baseline
Heat pain thresholds will be taken with a slowing increasing temperature probe. The temperature at which pain is first detected over repeated tests will be the heat pain threshold.
Discrimination
时间窗: Baseline
Perceived discrimination will be measured using the DISC-12. Each of the 35 items is scored from 0-3, giving a total overall score between 0 and 105.
Immune cell number
时间窗: Baseline
Blood samples will be assessed for absolute cell population numbers to include Th1, Th1, Th17, effector T, B and NK cells.
Depression
时间窗: Baseline
Depression will be assessed using the CES-D. Items are scored on a 0-3 scale. The possible range is 0-60, with higher scores reflecting greater depressive symptomatology.
Sleep quality
时间窗: Baseline
Sleep quality will be assessed using the insomnia severity index. The index will provide a score as follows: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe)
次要结局
- Adverse childhood events(Baseline)
- Body image(Baseline)
- Community connectedness(Baseline)
- Bodily pain(Baseline)
- Quality of life metrics(Baseline)
- Gender role expectation of pain(Baseline)
研究者
Robert Sorge
Associate Professor
University of Alabama at Birmingham