Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)

Per Rotbøll Nielsen

Status: Completed

Conditions: Inflammation; Hyperalgesia; Pain

Treatments: Drug: Hyperbaric Oxygen; Other: Normal ambient conditions

Study type: Interventional

Funder types: Other

Identifiers

NCT02025686

HBO12-04-2013

2011-41-6327 (Other Identifier)

Details and patient eligibility

About

The hypothesis of this investigation is to observe if HBO have an anti-inflammatory effect in humans induced by tonic heat stimulation. It has been shown in animal studies with rats that HBO could reduce the paw edema induced by carrageenan as an inflammatory agent. The authors are not aware of similar studies in human subjects investigating this effect of HBO. Aim: To investigate the anti-inflammatory effect of HBO by reducing the hyperalgesia induced by heat stimulation in healthy subjects and promote future research and understanding of the anti-inflammatory processes in humans. The primary endpoint is a reduced area of secondary hyperalgesia after HBO.

Enrollment: 16 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 18 yr Approved physical health examination Healthy Male

Exclusion criteria

• Arterial hypertension Chronic pain Claustrophobic tendency History of substance abuse Impaired cognitive abilities Inability to participate in quantitative sensory testing Incomplete understanding of Danish Neurological deficits Previous barotrauma or pneumothorax Previous head trauma Unable to equilibrate pressure in middle ear and/or sinuses

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Hyperbaric Oxygen

Experimental group

Description:

Subjects will breathe oxygen (FIO2 = 1.0) at 2.4 ATA in a hyperbaric chamber after the tonic heat stimulations. The duration of oxygen exposure is 90 min

Treatment:

Drug: Hyperbaric Oxygen

Other: Normal ambient conditions