Pain Outcomes Associated With Exogenous Hormone Therapy in Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorUniversity of Kansas Medical Center
About this trial
TRANSPIRE is an observational study of \~200 individuals who (1) will be initiating gender-affirming hormone therapy (GHT) or (2) are gender minority individuals who do not use GHT. The primary outcome will be to identify how the presence of chronic pain changes overtime with GHT through the use of surveys, quantitative sensory testing (QST), brain MRIs, and qualitative interviews.
Following recruitment and consent, participants will complete baseline survey measures and will repeat those measures at 1 months, 3 month, 6 months, and 12 months. QST measures, brain MRIs, and Qualitative Interviews will be offered to participants in cohort (1) and will be completed at baseline and 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent provided by the participant
Ages 18-50 years
English speaking
GM persons who have been deemed to be an appropriate medical candidate to take gender-affirming hormone therapy for gender incongruence -OR- GM persons who are not taking gender-affirming hormone therapy
Disqualifiers
Inability to provide informed consent
Age less than 18 years or greater than 50 years
Severe physical impairment (e.g., blindness, deafness, paraplegia)
Co-morbid medical conditions that may significantly impair physical functional status (e.g., history of non-skin malignancy, or autoimmune disorder)
Trial population
Gender minority individuals from within the greater Kansas City area
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Persons Initiating GHT
Group B: Gender Minority Persons Not Taking GHT
Trial outcomes
Primary outcomes
1
Prevalence of Chronic Pain in Gender Minority Adults Initiating GHT
The primary outcome is to measure the presence of chronic pain before and after the initiation of GHT. Participants will be asked if they have had pain on more than half the days of the last 3 months.
Time frame
Baseline and 1, 3, 6, and 12-months.2
fMRI Changes in Functional Connectivity
For Aim 2 (QST and MRI), the primary outcome is to identify changes in resting state functional connectivity (e.g., ACC - PAG) over time with GHT in GM persons on masculinizing GHT and GM persons on feminizing GHT.
Time frame
Baseline (pre-GHT) and 12-months (post-GHT)3
Qualitative Interview Outcome Measure
1\) To better understand the relationship between stress, loneliness, medical mistrust, affirmation treatment, chronic pain, and psychological functioning in GM persons. 2) To better understand the lived experiences of GM persons with and without chronic pain. 3) To better understand the lived experiences of GM persons and how gender-affirming care has impacted their overall physical and mental wellbeing.
Time frame
Baseline (pre-GHT) and 12-month (post-GHT)Secondary outcomes
1
Severity of Chronic Pain
For those GM participants with the presence of chronic pain, investigators will assess how pain severity NRS ratings change over time with GHT. This will be assessed using the Brief Pain Inventory (BPI) which assesses pain on a scale of 0-10 at its worst in the past 7 days, on average in the past 7 days, at its least in the past 7 days, and at the current time.
Time frame
Baseline and 1, 3, 6, and 12-months2
Magnitude of Nociplastic Pain
Investigators will use the 2016 Fibromyalgia Survey to assess the magnitude of pain. The 2016 FM survey consists of a body map score and Symptom Severity Index score that are added together to indicate the severity of Fibromyalgia. The higher the score, the higher the severity.
Time frame
Baseline and 1, 3, 6, and 12-months.3
Quantitative Sensory Testing within the fMRI
For Aim 2, the secondary outcomes will be to identify changes in QST parameters before and after GHT-initiation. Two QST measures will be completed during each fMRI scan and values will be compared. Brain activation during the painful QST sensations will be measured and compared between the two time points.
Time frame
Baseline (pre-GHT) and 12-months (post-GHT)4
Gray Matter Volume after initiating GHT
For Aim 2, gray matter may impact nerves and pain reception. The volume will be measured within the fMRI before and after initiation.
Time frame
Baseline (pre-GHT) and 12-months (post-GHT)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov