Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT05145595
Brief Summary:
Aim 1- To examine the differences in pain sensitivity between adolescents at early vs. mid pubertal status Aim 2- To determine the relationships between sex hormone levels and pain sensitivity Exploratory Aim 1- To determine the effect of pubertal maturation on pain sensitivity Exploratory Aim 2- To identify parameters related to who will develop chronic pain during puberty
Hypothesis 1- Adolescents in early pubertal status will have higher pain ratings and lower pain modulation capabilities compared to adolescents in mid puberal status.
Hypothesis 2- Pain sensitivity will be associated with sex hormone levels. Exploratory Hypothesis 1- As adolescents mature, they will have a decrease in pain sensitivity to experimental pain which will be related to changes in sex hormone levels.
Exploratory hypothesis 2- Female adolescents with greater pain sensitivity, lower testosterone levels and with a family history of pain would be at a higher risk to develop chronic pain
Detailed Description:
At baseline, participants will complete a 2.5-hours study session. In the study session, psychophysical assessments of thermal and pressure stimuli will be performed and sex hormone levels will be analyzed. In addition, demographic, social, pubertal maturation, behavioral and psychological factors will be collected via questionnaires.
In the optional follow-up portion, participants can complete short surveys every 3 months and/or return for study visits after 6 months and/or after every year depending on the participant's availability. The study visits will include the same procedures as the baseline study visit. Additional surveys regarding new symptoms of pain will be completed. In some cases, participants will meet a pediatric physician who will determine if they meet the criteria for any pain syndrome (for research purposes only).
Study:
NCT05145595
Study Brief:
Protocol Section:
NCT05145595