Pain Sensitivity Assessment During Puberty for Pain

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how puberty affects pain sensitivity, focusing on the influence of sex hormones on adolescents' pain perception. Researchers compare early and mid-puberty teens to determine differences in pain experience and coping. They aim to identify factors that might predict chronic pain development during puberty. This study suits healthy children aged 9-16 who speak English and do not have chronic pain, frequent headaches, or take regular pain medication. As an unphased trial, it offers a unique opportunity to contribute to understanding adolescent pain experiences and potentially improve future care.

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 prior data suggests that these assessments are safe for adolescents?

Research shows that methods like conditioned pain modulation (CPM) are well-tolerated. These methods help researchers understand how the body naturally manages pain. Studies have found that CPM and other ways of measuring pain sensitivity are safe and effectively assess pain responses in different groups, including children and teens.

The study includes various tests, all of which are non-invasive. This means they don't involve surgery or entering the body. Instead, they apply pressure or heat to the skin to observe the body's reactions. The research aims to understand pain better, not to treat it directly, so these tests are generally considered low-risk.

Overall, existing research supports the safety of these pain sensitivity tests for human participants, including adolescents. No serious side effects are known to be linked to these evaluations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to shed light on how pain sensitivity changes during puberty, which is a critical yet understudied area. Unlike existing treatments that focus on managing pain once it occurs, this trial investigates various ways the body perceives and modulates pain, such as cold pain tolerance and pressure pain thresholds. By understanding these mechanisms, scientists hope to develop more effective, personalized pain management strategies for adolescents in the future. This could lead to breakthroughs in preventing chronic pain conditions from developing during this pivotal stage of life.

What evidence suggests that this trial's assessments could be effective for understanding pain sensitivity during puberty?

This trial will assess pain sensitivity during puberty by examining various factors, including conditioned pain modulation (CPM) efficiency, which measures how well the body manages pain. Research has shown that CPM can be particularly informative in teenagers. The trial will also explore connections between different types of pain, as studies suggest that experiencing one kind of pain can indicate how others might be experienced. Additionally, the trial will investigate temporal summation, which refers to how pain builds up with repeated exposure, to understand individual pain sensitivity. These assessments aim to explore how hormonal changes during puberty might affect pain sensitivity, potentially explaining variations in pain perception among teenagers. ^{1 3 4 5 6}

Who Is on the Research Team?

Hadas Nahman-Averbuch, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11592744/

A Systematic Review and Meta-Analysis of Conditioned Pain ... The primary aim of this systematic review was to examine the efficacy of CPM in paediatric chronic pain populations (6–24-year-olds) compared to pain-free ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11966350/

Exploring the Spectrum of Temporal Summation and ... This study examines the spectrum and provides a distribution for TS and CPM values to better identify what may constitute a deficit in these mechanisms.

3. withpower.com withpower.com/trial/phase-hypersensitivity-1-2022-2a493

Pain Sensitivity Assessment During Puberty for Pain The research suggests that conditioned pain modulation (CPM) can effectively evaluate the body's natural pain control system, which may help understand pain ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0304395907007543

Principle components analysis of pain thresholds to ... We observed that pain thresholds were significantly correlated with each other. Principal component analysis indicated that their variance was attributable more ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0307556

Reliability and minimal detectable change of dynamic ... Temporal summation (TS) refers to an excitatory pain mechanism implying a gradual enhancement of pain perception during repeated or constant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11755398/

Pain profiles and variability in temporal summation of pain and ... This study describes the variability in temporal summation of pain (TSP) and conditioned pain modulation (CPM) in chronic musculoskeletal pain patients.