Childhood Adversity, Inflammatory Reactivity and Persistent Pain
CompletedNCT06127693
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- The Roles of Childhood Adversity and Inflammatory Reactivity in Promoting Pain and Fatigue After Provocation
- Conditions
- Chronic Pain
- Central Sensitisation
- Immune Response
- Adverse Childhood Experiences
- Interventions
- Drug: Tetravalent Influenza Vaccine
- Behavioral: High-frequency electrical stimulation
- Sponsor
- University of Cape Town
- Start date
- 2022-06-21
- Primary completion
- 2023-09-20
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- South Africa
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06127693