State of Hormones Impact Nociceptive Expression
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Study population will be chosen from the general public within the Birmingham as well as participants recruited through the Birmingham Aids Outreach (BAO), Magic City Acceptance Center (MCAC) and the Transgender Advocates Knowledgeable Empowering (TAKE).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Quantative sensory testing
BehavioralAll participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Blood Draw
Diagnostic testSample of blood will be taken.
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cis Man2 interventions
Group B: Cis Woman2 interventions
Group C: Transgender Man2 interventions
Group D: Transgender Woman2 interventions
Group E: Transgender Man plus Testosterone2 interventions
Group F: Transgender Woman plus Estrogen2 interventions
Trial outcomes
Primary outcomes
1
Experimental Heat Pain Thresholds
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.
Time frame
Baseline2
Experimental Pressure Pain Thresholds
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.
Time frame
Baseline3
Experimental Pain Sensitivity
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.
Time frame
Baseline4
Temporal Summation
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).
Time frame
BaselineSecondary outcomes
1
Community connectedness
All participants will have their perceived connectedness to the LGBTQ+ community assessed. Each of 7 items will be scored on a 3 (strongly agree) to 0 (strongly disagree) scale, resulting in a range of 0-21. Higher scores reflect greater connectedness to the LGBTQ+ community.
Time frame
Baseline2
Bodily pain
The presence of any mild pain will be assessed using the brief pain inventory. Items 3-6 will be scored from 0-10 to assess the severity of pain (40 as the most pain possible). Items 9A-9I will be scored and summated to assess pain interference with 0 reflecting no interference and 90 reflecting complete interference.
Time frame
Baseline3
Quality of life metrics
The SF-36 will be used to assess various aspects of quality of life including mood, activity, energy, general health, and pain. An overall score will be taken with a range of 0-100, with higher scores reflecting higher reported quality of life.
Time frame
Baseline4
Body image
The BIQLI will be sued to assess relative comfort with participants' perceived and experienced body image. The 10-item questionnaire uses a 7-point scoring system from -3 (very negative) to 3 (very positive) to rate statements about body image. Higher scores reflect more positive feelings about body image.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov