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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025686
• Other study ID #: HBO12-04-2013
• Secondary ID: 2011-41-6327
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: December 30, 2013
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperalgesia
• Inflammation
• Pain

Intervention

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)

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Per Rotbøll Nielsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Hyperbaric Oxygen Therapy on Pain and Inflammation induced by Tonic Heat Stimulation in Human Volunteers	Inflammation	8 weeks	Yes
Secondary	Pain on Pain Scores on the Visual Analog Scale		8 weeks	Yes