Pain Sensitivity Assessment During Puberty for Pain

Overseen By Alana McMichael, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Opioids, Antidepressants

Disqualifiers: Pregnancy, Chronic pain, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that participants do not regularly use pain medications like opioids or antidepressants. If you are taking these regularly, you may need to stop to participate.

What data supports the effectiveness of the treatment for pain sensitivity assessment during puberty?

The research suggests that conditioned pain modulation (CPM) can effectively evaluate the body's natural pain control system, which may help understand pain sensitivity. Studies show that CPM can reliably measure changes in pain thresholds, indicating its potential usefulness in assessing pain modulation. ^{1 2 3 4 5}

Is the pain sensitivity assessment during puberty generally safe for humans?

The studies reviewed focus on the reliability and effectiveness of pain sensitivity assessments like conditioned pain modulation (CPM) in healthy individuals, but they do not report any specific safety concerns or adverse effects, suggesting that these assessments are generally safe for human participants. ^{1 2 3 6 7}

How does this treatment for pain sensitivity during puberty differ from other treatments?

This treatment is unique because it focuses on assessing pain sensitivity and modulation during puberty using conditioned pain modulation (CPM), which involves applying a painful stimulus to reduce pain perception elsewhere in the body. Unlike standard pain treatments that often involve medication, this approach evaluates the body's natural pain control mechanisms. ^{1 2 3 4 5}

Research Team

Hadas Nahman-Averbuch, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for healthy boys and girls aged 9-16 who speak English. It's not for those who are pregnant, have chronic pain or frequent headaches, psychiatric or neurological issues, sensation loss in limbs to be tested, conditions affecting puberty, or take regular pain meds.

Inclusion Criteria

I am a healthy male or female.

I am between 9 and 16 years old.

I speak English.

Exclusion Criteria

I cannot feel anything in one of my limbs.

I often have headaches, more than 5 times a month.

I have conditions or take birth control that affects my hormone levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a 2.5-hour study session including psychophysical assessments of thermal and pressure stimuli, and analysis of sex hormone levels.

1 day

1 visit (in-person)

Follow-up

Participants can complete short surveys every 3 months and/or return for study visits after 6 months and/or after every year. Study visits include the same procedures as the baseline visit.

3 years

Surveys every 3 months, optional visits every 6 months or annually

Treatment Details

Interventions

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

Trial Overview The study tests how sensitive kids at different stages of puberty are to pain using various methods like heat and pressure. It looks at whether hormone levels affect this sensitivity and if changes during puberty might predict future chronic pain risk.

Participant Groups

Group I: Psychophysical assessments of experimental pain Experimental Treatment 10 Interventions

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).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

In a study of 35 healthy volunteers, researchers found that effective conditioned pain modulation (CPM) is linked to stronger connectivity between the periaqueductal grey (PAG) and brain regions involved in pain processing, suggesting a neural basis for pain modulation efficiency.

The results indicate that individuals with better pain modulation may have enhanced functional connectivity in brain areas that help manage pain, which could serve as potential biomarkers for assessing vulnerability or resilience to chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conditioned pain modulation is associated with heightened connectivity between the periaqueductal grey and cortical regions. Harrison, R., Gandhi, W., van Reekum, CM., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

Test-retest reliability of pressure pain threshold and heat pain threshold as test stimuli for evaluation of conditioned pain modulation. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Reference values of conditioned pain modulation. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Comparing test-retest reliability and magnitude of conditioned pain modulation using different combinations of test and conditioning stimuli. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

The relationship between sensitivity to pain and conditioned pain modulation in healthy people. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

The role of stimulation parameters on the conditioned pain modulation response. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

The inter- and intra-individual variance in descending pain modulation evoked by different conditioning stimuli in healthy men. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Conditioned pain modulation is associated with heightened connectivity between the periaqueductal grey and cortical regions. [2022]