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

NCT02025686 | Completed DMC

• 2 other identifiers: HBO12-04-20132011-41-6327
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Inflammation; Hyperalgesia

Keywords

Pain; Inflammation; Hyperalgesia; burn injury; Hyperbaric Oxygen

Outcome Measures

Primary Outcomes (1)

• The effect of Hyperbaric Oxygen Therapy on Pain and Inflammation induced by Tonic Heat Stimulation in Human Volunteers

  Inflammation

  8 weeks

Secondary Outcomes (1)

• Pain on Pain Scores on the Visual Analog Scale

  8 weeks

Study Arms (1)

Hyperbaric Oxygen

EXPERIMENTAL

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; Other: Normal ambient conditions

Interventions

Hyperbaric Oxygen DRUG

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 OTHER

Normal ambient conditions (1 ATA, FIO2 = 0.21)

Hyperbaric Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 yr Approved physical health examination Healthy Male

You may not qualify if:

• 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

Sponsors & Collaborators

• Per Rotbøll Nielsen: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Pain; Inflammation; Hyperalgesia; Burns

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: January 1, 2014
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 1, 2014

Record last verified: 2013-12

Locations

DK (1)