Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT05145595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2021-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Sensitivity During Puberty
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
The Effect of Puberty on Pain Sensitivity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: