Observational Study on Hormones and Pain Sensitivity

This study is looking at how gender identity and hormone use might affect how people experience pain. Researchers want to understand if there are differences in pain sensitivity between cisgender (people whose gender identity matches their sex assigned at birth) and transgender individuals, and how hormones might play a role. You could be eligible if you are between 18 and 65 years old, understand English, and have been on or off hormone treatment for at least 6 months. The study will measure your sensitivity to heat, pressure, and cold pain. The goal is to see if gender identity and hormone status influence pain sensitivity, and if social and psychological factors also contribute. The study is currently recruiting 120 participants across different gender identities and hormone statuses.

Study design
This is an observational study with a planned enrollment of 120 participants. It is not a treatment study, but rather aims to understand existing differences.
What's involved
You would undergo quantitative sensory testing for about 1 hour, which involves applying painful heat, mechanical, and cold stimuli. A blood sample will also be taken.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05787470

State of Hormones Impact Nociceptive Expression

Recruiting
Not specifiedAges 18–65Observational
University of Alabama at Birmingham
~120 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Quantative sensory testingBlood Draw

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Experimental Heat Pain Thresholds
Measured over Baseline
+11 more outcomes measured
Pain
Gender Identity
1 sites across 1 states
Alabama1
  • Robert Sorge, Phd · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham Department of Psychology

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Eligibility criteria

Inclusion

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

Exclusion

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.
  • Experimental Heat Pain ThresholdsBaseline

    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.

  • Experimental Pressure Pain ThresholdsBaseline

    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.

  • Experimental Pain SensitivityBaseline

    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.

  • Temporal SummationBaseline

    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).

  • Conditioned Pain ModulationBaseline

    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.

  • Sleep qualityBaseline

    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)

  • DepressionBaseline

    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.

  • Social SupportBaseline

    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.

  • DiscriminationBaseline

    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.

  • Hormone levelsBaseline

    Testosterone and estradiol will be assessed in blood samples.

  • Immune cell numberBaseline

    Blood samples will be assessed for absolute cell population numbers to include Th1, Th1, Th17, effector T, B and NK cells.

  • Immune cell cytokine productionBaseline

    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.