Childhood Adversity, Inflammatory Reactivity and Persistent Pain

NCT06127693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2023-11-13

No results posted yet for this study

Summary

The goal of this observational study is to investigate how adverse experiences during childhood are linked to people experiencing persistent pain and fatigue in adulthood.

The questions the investigators aim to answer are:

1. Does participant-reported childhood adversity predict levels of IL-6 and TNF-α after in vitro provocation of whole blood using endotoxin?
2. Do levels of IL-6 and TNF-α after in vitro immune provocation using endotoxin predict vulnerability to persistent pain and fatigue after in vivo immune provocation (tetravalent influenza vaccine)?
3. Do levels of IL-6 and TNF-α after in vitro immune provocation using endotoxin predict vulnerability to persistent pain and fatigue after in vivo neural provocation?

For this study, the investigators will recruit and enrol 96 healthy human adults (18 - 65 years old) with a range of adverse experiences during childhood. Participants will attend 2 study sessions during which the investigators will take a sample of blood, assess pressure pain threshold before and after cold water immersion, assess heart rate variability, and assess the surface area of secondary skin hypersensitivity after electrical stimulation. At the end of the first session, participants will receive the influenza vaccination.

Conditions

  • Chronic Pain
  • Central Sensitisation
  • Immune Response
  • Adverse Childhood Experiences

Interventions

DRUG

Tetravalent Influenza Vaccine

All participants will receive the tetravalent influenza vaccine

BEHAVIORAL

High-frequency electrical stimulation

All participants will receive High-frequency electrical stimulation

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Victoria J Madden, PhD · University of Cape Town

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-09-20
Completion
2023-09-20

Countries

  • South Africa

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127693 on ClinicalTrials.gov