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NCT06127693: CAIR

Childhood Adversity, Inflammatory Reactivity and Persistent Pain

Completed Last updated 13 November 2023
What this trial tests

trial testing Tetravalent Influenza Vaccine in Chronic Pain in 101 participants. Completed in 20 September 2023.

Timeline
21 June 2022
Primary endpoint
20 September 2023
20 September 2023

Quick facts

Lead sponsorUniversity of Cape Town
StatusCompleted
Study typeOBSERVATIONAL
Enrollment101
Start date21 June 2022
Primary completion20 September 2023
Estimated completion20 September 2023
Sites1 location across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

University of Cape Town

Who can join

Adults 18 to 65, any sex, with Chronic Pain or Central Sensitisation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Inflammatory reactivity is unrelated to childhood adversity or provoked modulation of nociception.
    Bedwell GJ, Mqadi L, Kamerman P, Hutchinson MR, et al · · 2025 · cited 3× · PMID 40372281 · DOI 10.1097/j.pain.0000000000003658

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Other recruiting trials for Chronic Pain

Currently open trials in the same condition.

Other University of Cape Town trials

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