PainSHINENCT05787470
State of Hormones Impact Nociceptive Expression
An observational study of Pain and Gender Identity, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Gender Identity
- What is being tested?
- Quantative sensory testing and Blood Draw
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tammie Quinn, BA, (205) 934-8743, tquinn@uab.edu
About this study
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.
Read the detailed description
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.
Hypotheses: Hormone levels will be directly related to immune cell populations. CM, TW and TM+T will have increased frequencies of NK and CD8+ cells than CW, TM and TW+E. The presence of estradiol will be positively correlated with stimulated cytokine release in T cells.
Inclusion criteria will include:
- self-identification as one of the above gender identities; 2) age between 18-65; 3) understanding of verbal and written English. There will be considerable heterogeneity within the trans population with respect to gender/sexual expression. Whereas the investigators feel that these factors are important to consider, in order to enhance recruitment and inclusion, the investigators will focus on self-reported gender identity and note other variables of interest. With respect to hormone use, only participants that have been on/off hormone treatment for at least 6 months will be eligible. In both cases, this allow for stabilization of hormone levels and reduced variability. At this time the investigators will restrict our recruitment to self-identified trans and cisgender participants, but recognize that very little research exists on non-binary or genderfluid groups.
Exclusion criteria will be the following:
- pain in at least 3/7 days/week for the past 3 months; 2) HIV positive diagnosis; 3) cardiovascular or pulmonary disease; 4) regular use of opioid pain medications; 5) uncontrolled hypertension (i.e. SBP/DBP of > 150/95); 6) current illness accompanied by fever (body temperature >38 °C); 7) active use of oral contraceptives; 8) prostatectomy, hysterectomy or oophorectomy; 9) hospitalization due to psychiatric illness within the last 6 months. The investigators acknowledge that the rates of HIV are higher in the South and in gender minority populations 46, but our investigation of immune cell reactivity (Aim 3) necessitates this exclusion.
This study will consist of a single visit which will include the following:
Blood Draw: A small amount of blood (2 tsp) will be drawn by a trained and certified nurse. The investigators will be analyzing this blood to determine the participants' levels of oxidative stress. (5 minutes)
Questionnaires: The investigators will be administering a number of questionnaires to assess various aspects related to quality of life, experiences of stigma, depression and social support. These are standard measures for this type of study and will provide necessary information about factors that may influence pain sensitivity. (40 minutes)
Body Measurements: Body weight and height will be measured. The investigators will also be measuring the participants' blood pressure. (5 minutes)
Pain Testing: This will consist of a number of sensitivity tests. (70 minutes)
- Pressure: The investigators will use a handheld probe that has a small rubber tip. This will produce a pressure sensation and the pressure pain threshold will be obtained.
- Heat: Heat pain sensitivity will be tested with a thermal sensory testing machine used widely in clinical settings. This machine has a small square piece that is used to apply heat to the skin. The amount of heat is controlled by a computer. One or more of the following types of heat stimuli will be delivered: 1) a slowly increasing heat stimulus; 2) a series of 5 heat pulses. These heat pulses will be repeated at different temperatures.
- Cold: Cold sensitivity will be assessed with the cold pressor task. The hand is placed into cold water (4-10 C) for up to 60 seconds. With the fingers splayed, the participant is asked for their pain ratings at 30 and 60 seconds.
- Combined pressure and cold: The investigators will use a handheld device with a small rubber tip to apply pressure. As soon as pain is reported, the pressure will be removed. Next, the hand will be immersed into cold water. After 20 seconds, the pressure stimulator will again be applied.
- Conditions
- Pain, Gender Identity
- Being tested
- Quantative sensory testing, Blood Draw
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantative sensory testingBehavioural
Also called QST
All 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 DrawDiagnostic test
Also called Venipuncture
Sample of blood will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Cis Man | Person assigned male at birth and whose gender identity is man. Receives: Behavioral: Quantative sensory testing; Diagnostic Test: Blood Draw | |
| Cis Woman | Person assigned female at birth and whose gender identity is woman. Receives: Behavioral: Quantative sensory testing; Diagnostic Test: Blood Draw | |
| Transgender Man | Person assigned female at birth and whose gender identity is man. Receives: Behavioral: Quantative sensory testing; Diagnostic Test: Blood Draw | |
| Transgender Woman | Person assigned male at birth and whose gender identity is woman. Receives: Behavioral: Quantative sensory testing; Diagnostic Test: Blood Draw | |
| Transgender Man plus Testosterone | Person assigned female at birth and whose gender identity is man and are currently on testosterone replacement. Receives: Behavioral: Quantative sensory testing; Diagnostic Test: Blood Draw | |
| Transgender Woman plus Estrogen | Person assigned male at birth and whose gender identity is woman and are currently on estrogen replacement. Receives: Behavioral: Quantative sensory testing; Diagnostic Test: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Hormone levels
Testosterone and estradiol will be assessed in blood samples.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (6)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Gender role expectation of pain
The GREP will be used to determine how participants feel about their gender role (and others) as it relates to experiencing pain. For each question, the participant indicates on a 10-point scale from "far less" to "far greater" to what extent they agree/disagree with statements.
Measured: Baseline
Adverse childhood events
The ACE questionnaire will be sued to determine the presence and number of adverse events experienced by participants.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Mar 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Robert Sorge, University of Alabama at Birmingham
- Investigators
- Robert Sorge, Phd, Principal investigator, University of Alabama at Birmingham Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787470
- Sponsor's protocol ID
- IRB-300009452
- Other IDs
- 5R01NR019417
- Acronym
- SHINE
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State of Hormones Impact Nociceptive Expression
- ClinicalTrials.gov ID
- NCT05787470
- Acronym / sponsor ID
- SHINE / IRB-300009452
- Conditions
- Pain, Gender Identity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Hypotheses: Hormone levels will be directly related to immune cell populations. CM, TW and TM+T will have increased frequencies of NK and CD8+ cells than CW, TM and TW+E. The presence of estradiol will be positively correlated with stimulated cytokine release in T cells.
Inclusion criteria will include:
- self-identification as one of the above gender identities; 2) age between 18-65; 3) understanding of verbal and written English. There will be considerable heterogeneity within the trans population with respect to gender/sexual expression. Whereas the investigators feel that these factors are important to consider, in order to enhance recruitment and inclusion, the investigators will focus on self-reported gender identity and note other variables of interest. With respect to hormone use, only participants that have been on/off hormone treatment for at least 6 months will be eligible. In both cases, this allow for stabilization of hormone levels and reduced variability. At this time the investigators will restrict our recruitment to self-identified trans and cisgender participants, but recognize that very little research exists on non-binary or genderfluid groups.
Exclusion criteria will be the following:
- pain in at least 3/7 days/week for the past 3 months; 2) HIV positive diagnosis; 3) cardiovascular or pulmonary disease; 4) regular use of opioid pain medications; 5) uncontrolled hypertension (i.e. SBP/DBP of > 150/95); 6) current illness accompanied by fever (body temperature >38 °C); 7) active use of oral contraceptives; 8) prostatectomy, hysterectomy or oophorectomy; 9) hospitalization due to psychiatric illness within the last 6 months. The investigators acknowledge that the rates of HIV are higher in the South and in gender minority populations 46, but our investigation of immune cell reactivity (Aim 3) necessitates this exclusion.
This study will consist of a single visit which will include the following:
Blood Draw: A small amount of blood (2 tsp) will be drawn by a trained and certified nurse. The investigators will be analyzing this blood to determine the participants' levels of oxidative stress. (5 minutes)
Questionnaires: The investigators will be administering a number of questionnaires to assess various aspects related to quality of life, experiences of stigma, depression and social support. These are standard measures for this type of study and will provide necessary information about factors that may influence pain sensitivity. (40 minutes)
Body Measurements: Body weight and height will be measured. The investigators will also be measuring the participants' blood pressure. (5 minutes)
Pain Testing: This will consist of a number of sensitivity tests. (70 minutes)
- Pressure: The investigators will use a handheld probe that has a small rubber tip. This will produce a pressure sensation and the pressure pain threshold will be obtained.
- Heat: Heat pain sensitivity will be tested with a thermal sensory testing machine used widely in clinical settings. This machine has a small square piece that is used to apply heat to the skin. The amount of heat is controlled by a computer. One or more of the following types of heat stimuli will be delivered: 1) a slowly increasing heat stimulus; 2) a series of 5 heat pulses. These heat pulses will be repeated at different temperatures.
- Cold: Cold sensitivity will be assessed with the cold pressor task. The hand is placed into cold water (4-10 C) for up to 60 seconds. With the fingers splayed, the participant is asked for their pain ratings at 30 and 60 seconds.
- Combined pressure and cold: The investigators will use a handheld device with a small rubber tip to apply pressure. As soon as pain is reported, the pressure will be removed. Next, the hand will be immersed into cold water. After 20 seconds, the pressure stimulator will again be applied.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cis Man | – | Behavioral: Quantative sensory testing, Diagnostic Test: Blood DrawPerson assigned male at birth and whose gender identity is man. |
| Cis Woman | – | Behavioral: Quantative sensory testing, Diagnostic Test: Blood DrawPerson assigned female at birth and whose gender identity is woman. |
| Transgender Man | – | Behavioral: Quantative sensory testing, Diagnostic Test: Blood DrawPerson assigned female at birth and whose gender identity is man. |
| Transgender Woman | – | Behavioral: Quantative sensory testing, Diagnostic Test: Blood DrawPerson assigned male at birth and whose gender identity is woman. |
| Transgender Man plus Testosterone | – | Behavioral: Quantative sensory testing, Diagnostic Test: Blood DrawPerson assigned female at birth and whose gender identity is man and are currently on testosterone replacement. |
| Transgender Woman plus Estrogen | – | Behavioral: Quantative sensory testing, Diagnostic Test: Blood DrawPerson assigned male at birth and whose gender identity is woman and are currently on estrogen replacement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantative sensory testingAlso: QSTAll 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. | Behavioural | Cis Man, Cis Woman, Transgender Man, Transgender Man plus Testosterone, Transgender Woman, Transgender Woman plus Estrogen |
| Blood DrawAlso: VenipunctureSample of blood will be taken. | Diagnostic test | Cis Man, Cis Woman, Transgender Man, Transgender Man plus Testosterone, Transgender Woman, Transgender Woman plus Estrogen |
Primary outcome
Experimental Heat Pain Thresholds
Time frame: 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.
Experimental Pressure Pain Thresholds
Time frame: 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.
Experimental Pain Sensitivity
Time frame: 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.
Temporal Summation
Time frame: 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).
Conditioned Pain Modulation
Time frame: 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.
Sleep quality
Time frame: 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)
Depression
Time frame: 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.
Social Support
Time frame: 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.
Discrimination
Time frame: 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.
Hormone levels
Time frame: Baseline
Testosterone and estradiol will be assessed in blood samples.
Immune cell number
Time frame: Baseline
Blood samples will be assessed for absolute cell population numbers to include Th1, Th1, Th17, effector T, B and NK cells.
Immune cell cytokine production
Time frame: 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.
6 secondary outcomes
Community connectedness
Time frame: Baseline
Bodily pain
Time frame: Baseline
Quality of life metrics
Time frame: Baseline
Body image
Time frame: Baseline
Gender role expectation of pain
Time frame: Baseline
Adverse childhood events
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Sorge, Phd principal investigator
University of Alabama at Birmingham Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Gender Identity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tammie Quinn, BA ((205) 934-8743, tquinn@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experimental Heat Pain Thresholds (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.