Clinical trial NCT05145595: Pain Sensitivity During Puberty
Official title: The Effect of Puberty on Pain Sensitivity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain
Keywords: Pain
Puberty
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria

1. Healthy males and females
2. 9-16 years old
3. English speakers

Exclusion Criteria

Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:

1. Pregnancy
2. Chronic Pain or frequent headaches (\>5 headache /month)
3. Psychiatric or neurological disorders
4. Lack of sensation in the testable limb
5. Disorders associated with pubertal maturation or usage of contraceptive pills that affect sex hormone levels
6. Regular use of pain medications (e.g., opioids, antidepressants).

Primary outcomes:
measure: Pain ratings for heat stimuli
timeFrame: 3 years
measure: Pain ratings for cold stimuli
timeFrame: 3 years
measure: Conditioned pain modulation
timeFrame: 3 years
measure: Testosterone levels
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hadas Nahman-Averbuch, PhD
role: PRINCIPAL_INVESTIGATOR
References: