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Pain Sensitivity During Puberty

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The Washington University

Status

Completed

Conditions

Pain

Treatments

Behavioral: Pressure pain thresholds (PPT)
Device: Thermal Sensory Analyzer
Behavioral: Conditioned pain modulation (CPM) efficiency
Behavioral: Cold pain tolerance
Behavioral: Offset analgesia efficiency
Device: Mechanical Stimuli
Behavioral: Mechanical temporal summation
Device: Pressure Stimuli
Behavioral: Thermal pain thresholds
Behavioral: Pain Ratings

Study type

Interventional

Funder types

Other

Identifiers

NCT05145595
202109120

Details and patient eligibility

About

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

Full 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).

Enrollment

36 patients

Sex

All

Ages

9 to 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

Psychophysical assessments of experimental pain
Experimental group
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).
Treatment:
Behavioral: Pain Ratings
Behavioral: Thermal pain thresholds
Behavioral: Mechanical temporal summation
Device: Pressure Stimuli
Behavioral: Offset analgesia efficiency
Device: Mechanical Stimuli
Behavioral: Cold pain tolerance
Behavioral: Conditioned pain modulation (CPM) efficiency
Device: Thermal Sensory Analyzer
Behavioral: Pressure pain thresholds (PPT)

Trial contacts and locations

1

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Central trial contact

Alana McMichael, MA

Data sourced from clinicaltrials.gov

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