Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

120

participants targeted

Target at P50-P75 for all trials

Timeline

3mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.4 years study duration

Study Progress93%

Mar 2023Jul 2026

Study Start

First participant enrolled

March 1, 2023

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed

25 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

March 3, 2023

Last Update Submit

March 9, 2026

Conditions

Pain Gender Identity

Outcome Measures

Primary Outcomes (12)

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.
Baseline
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.
Baseline
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.
Baseline
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).
Baseline
Conditioned Pain Modulation
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.
Baseline
Sleep quality
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)
Baseline
Depression
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.
Baseline
Social Support
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.
Baseline
Discrimination
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.
Baseline
Hormone levels
Testosterone and estradiol will be assessed in blood samples.
Baseline
Immune cell number
Blood samples will be assessed for absolute cell population numbers to include Th1, Th1, Th17, effector T, B and NK cells.
Baseline
Immune cell cytokine production
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.
Baseline

Secondary Outcomes (6)

Community connectedness
Baseline
Bodily pain
Baseline
Quality of life metrics
Baseline
Body image
Baseline
Gender role expectation of pain
Baseline
+1 more secondary outcomes