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

Not Applicable

Completed

• Conditions: Pain; Inflammation; Hyperalgesia
• Interventions: Drug: Hyperbaric Oxygen; Other: Normal ambient conditions

• Registration Number: NCT02025686
• Lead Sponsor: Per Rotbøll Nielsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Status Verified: 2013-12
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-30
• Last Update Submitted: 2013-12-30
• Study First Posted: 2014-01-01
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hyperbaric Oxygen	Hyperbaric Oxygen	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
Hyperbaric Oxygen	Normal ambient conditions	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

Primary Outcome Measures

Name	Time	Method
The effect of Hyperbaric Oxygen Therapy on Pain and Inflammation induced by Tonic Heat Stimulation in Human Volunteers	8 weeks	Inflammation

Secondary Outcome Measures

Name	Time	Method
Pain on Pain Scores on the Visual Analog Scale	8 weeks

Trial Locations

Locations (1)

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark