CompletedNot Applicable

Childhood Adversity, Inflammatory Reactivity and Persistent Pain

South Africa101 participantsStarted 2022-06-21

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between the ages of 18 and 65 years old. Exclusion Criteria: * Incompetence to consent and participate, e.g. acute psychosis or high suicide risk. * Pregnancy, * Electrical implants (e.g. pace-maker), * Metal implants in the forearm, * Tattoos on the forearm, * Any visible injury or open wounds in the forearm, * Known history of allergic reactions to vaccines, * Has received the current season's influenza vaccine, * Chronic pain (pain on most days for the past 3 months), * Diabetes Mellitus, * Peripheral vascular disease, * Sensory impairment in the forearm, shoulder and lower back, * Use of medication that could later skin sensitivity (e.g. analgesic medication, immune modulators, topical medical creams), * Cardiovascular disorders, * Medication that alters immune function (e.g. NSAIDs, steroids), * Smoking habit, * Febrile illness in the preceding 4 weeks.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Childhood Trauma Questionnaire-Short form

Timeframe: Baseline

Provoked inflammatory response

Timeframe: Baseline

Secondary hypersensitivity (surface area)

Timeframe: 30 minutes, 45 minutes and 60 minutes after the high-frequency electrical stimulation (neural provocation)

Conditioned pain modulation

Timeframe: Baseline and 24 hours after the influenza vaccine (immune provocation).

Temporal summation

Timeframe: Baseline and 24 hours after the influenza vaccine (immune provocation).

Trial details

NCT IDNCT06127693

SponsorUniversity of Cape Town

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-20

View on ClinicalTrials.gov More Chronic Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Childhood Trauma Questionnaire-Short form

Timeframe: Baseline

Provoked inflammatory response

Timeframe: Baseline

Secondary hypersensitivity (surface area)

Timeframe: 30 minutes, 45 minutes and 60 minutes after the high-frequency electrical stimulation (neural provocation)

Conditioned pain modulation

Timeframe: Baseline and 24 hours after the influenza vaccine (immune provocation).

Temporal summation

Timeframe: Baseline and 24 hours after the influenza vaccine (immune provocation).