Clinical trial

The Roles of Childhood Adversity and Inflammatory Reactivity in Promoting Pain and Fatigue After Provocation

Name
HREC REF 560/2021
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.
Trial arms
Trial start
2022-06-21
Estimated PCD
2023-09-20
Trial end
2023-09-20
Status
Completed
Treatment
Tetravalent Influenza Vaccine
All participants will receive the tetravalent influenza vaccine
Arms:
Mild childhood adversity (control), Moderate childhood adversity, Severe childhood adversity
Other names:
flu vaccine
High-frequency electrical stimulation
All participants will receive High-frequency electrical stimulation
Arms:
Mild childhood adversity (control), Moderate childhood adversity, Severe childhood adversity
Size
101
Primary endpoint
Childhood Trauma Questionnaire-Short form
Baseline
Provoked inflammatory response
Baseline
Secondary hypersensitivity (surface area)
30 minutes, 45 minutes and 60 minutes after the high-frequency electrical stimulation (neural provocation)
Conditioned pain modulation
Baseline and 24 hours after the influenza vaccine (immune provocation).
Temporal summation
Baseline and 24 hours after the influenza vaccine (immune provocation).
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood plasma'}, 'enrollmentInfo': {'count': 101, 'type': 'ACTUAL'}}
Updated at
2023-11-13

1 organization

1 product

4 indications

Indication
Chronic Pain
Indication
immune response