Experimental human inflammation model in healthy subjects (induction of a transient, sterile neurogenic skin reddening/inflammation via a controlled thermal stimulus to simulate pathophysiological primary responses [triple response] and spinal reflex activity).
Conditions
Interventions
Group 1: Standardized osteopathic joint mobilization (Flare Inhibition, FI) of all anatomical joints located between the stimulated skin area and the corresponding spinal cord segments. The objective
Sponsors
Dresden International University (DIU) / Osteopathie Schule Deutschland (OSD)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Provision of written informed consent to participate in the study prior to enrollment.
Exclusion criteria
Exclusion criteria: - Local skin lesions, defects, or structural alterations in the planned area of examination (e.g., scars, tattoos, acute inflammation). - Acute febrile infections. - Neuropathies (such as vasculitis, amyloidosis, reflex dystrophy/CRPS, small fiber neuropathy) and their hereditary, metabolic, infectious, autoimmune, or geriatric triggers and comorbidities (e.g., Fabry disease, diabetes mellitus, vitamin B12 deficiency, HIV, hepatitis B/C, Raynaud's phenomenon, Alzheimer's disease, etc.). - Diagnosed osteoporosis (grade 1 or higher) to ensure maximum subject safety during mobilization. - Consumption of neurotoxic substances (alcohol) or vasoactive substances (caffeine, nicotine) within 4 hours prior to the measurement. - Thermal exposure or stress to the body or testing area (e.g., sauna, sunbathing, hot shower) within 4 hours prior to the measurement. - Intake of non-steroidal anti-inflammatory drugs (NSAIDs) or antihistamines within 24 hours prior to the measurement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and methodological validity of the study protocol for a future RCT (evaluation of recruitment and drop-out rates, sensitivity and technical failure rate of infrared thermography, data quality, time required for data collection, quality of blinding [assessed via Certainty-Expectancy Questionnaire and deblinding question], and statistical parameters including variance, RMSE, and Cohen's d). | — |
Secondary
| Measure | Time frame |
|---|---|
| Extent of neurogenic inflammation (inhibition of the flare response) in a group comparison (active vs. sham) following a controlled thermal stimulus. Metric: Change in skin temperature within the target area (measured via infrared thermography [IRT] in degrees Celsius). Timepoints: A total of 14 timepoints. Main evaluation timepoints: immediately before stimulation (baseline), directly after stimulation, and at 210 seconds. | — |
Countries
Germany
Contacts
Public ContactTobias Kühl
Dresden International University (DIU) / Osteopathie Schule Deutschland (OSD)
Outcome results
None listed