Perception of Pain During Gender Affirming Hormone Therapy

Официальное название

Changes in Pain and Perception Thresholds Due to Gender Affirming Hormone Therapy: a Prospective Exploratory Cohort Study

Обзор

It is known from the literature that women and men differ in their perception of pain. Why this is the case has not been conclusively clarified. Sex hormones could have a significant influence on this. The study team suspects that the classic hormone status of women is responsible for the lower pain threshold compared to men. People undergoing gender affirming therapy receive biologically opposite-sex hormones in order to adapt their external appearance as well as their voice, emotional life etc. to the desired gender. The aim of this study is to longitudinally record whether the intake of opposite-sex sex hormones leads to a change in pain and perception thresholds in this patient collective. To this end, potential study participants will be informed about the study and asked whether they would like to participate before the start of hormone therapy during their first visit to the transgender outpatient clinic. If consent is given, a questionnaire on mental health (PHQ 9), a blood sample to determine the hormone status and the first QST (quantitative sensory testing) measurement are then carried out. The second measurement with blood sampling takes place 3-4 weeks after the first measurement. The 3rd and 4th measurements with blood sampling are taken 3 and 6 months respectively after the first measurement. The PHQ 9 is measured again at the time of the last measurement. Study participation ends after a total of 6 months. The blood samples, the PHQ 9 and the QST measurements have no influence on the treatment of the study participants.

Вмешательства

• Диагностический тест Quantitative Sensory Testing
  Quantitative sensory testing (QST) is a psychophysical test procedure. With the help of calibrated stimuli and subjective sensory information, the functional state of the somatosensory system of a subject or patient is examined with regard to the expression of clinical signs. The test includes: * Cold detection threshold * Warm detection threshold * Paradoxical heat sensation * Cold pain threshold * Heat pain threshold * Mechanical detection threshold * Mechanical pain threshold * Mechanical p
• Диагностический тест Patient Health Questionnaire 9
  The Patient Health Questionnaire 9 (PHQ-9), a validated and internationally used health questionnaire, will also be completed twice at the first study day before the sex hormone therapy is initiated and during the last study day in month 6. The questionnaire consists of 9 items on the topic of mental well-being.
• Диагностический тест Hormone concentrations
  Blood concentrations of the following laboratory parameters will be determined: * Follicle stimulating hormone (FSH) * Luteotropic hormone (LH) * Prolactin (PRL) * Oestradiol (E2) * Sex hormone-binding globulin (SHBG) * Testosterone

Первичные конечные точки

• Cold detection threshold [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Warm detection threshold [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Thermal sensory limen [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Paradoxical heat sensation [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Cold pain threshold [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Heat pain threshold [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Mechanical detection threshold [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Mechanical pain threshold [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Mechanical pain sensitivity [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Dynamic mechanical allodynia [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]

Вторичные конечные точки (7)

• Patient Health Questionnaire 9 [Срок оценки: At the time of enrollment and on the last study day after 6 months.]
• Hormone concentrations (follicle stimulating hormone) [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Hormone concentrations (luteotropic hormone) [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Hormone concentrations (prolactin) [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Hormone concentrations (oestradiol) [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Hormone concentrations (sex hormone-binding globulin) [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]
• Hormone concentrations (testosterone) [Срок оценки: At the time of enrollment and after 3-4 weeks, 3 months and 6 months.]

Критерии участия

Критерии включения

• ≥ 18 years of age
• Assigned female at birth (AFAB)
• Diagnosed gender identity disorder/gender dysphoria and planned therapy with testosterone OR
• ≥ 18 years of age
• Assigned male at birth (AMAB)
• Diagnosed gender identity disorder/ gender dysphoria and planned therapy with estradiol

Критерии исключения

• Any sex hormone intake during the last 6 months
• Acute or chronic pain
• Polyneuropathy
• Diagnosis of alcohol or drug addiction
• BMI under 18 or over 35
• Pregnancy
• Breastfeeding
• Pharmacological analgesic therapy within the previous 7 days before each examination
• History of significant trauma or surgery to the hands with residual neurological deficit or pain.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австрия · 1 центр

• Mecial University of Vienna — Vienna

Идентификаторы

NCT: NCT07148921 · 1103/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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