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

Sponsor

Per Rotbøll Nielsen (Other)

Overall Status

Completed

CT.gov ID

NCT02025686

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Inflammation Hyperalgesia	Drug: Hyperbaric Oxygen Other: Normal ambient conditions	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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. Other: Normal ambient conditions Normal ambient conditions (1 ATA, FIO2 = 0.21)

Arm

Intervention/Treatment

Experimental: 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

Drug: 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.

Other: Normal ambient conditions

Normal ambient conditions (1 ATA, FIO2 = 0.21)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Pain on Pain Scores on the Visual Analog Scale [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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