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OpenTrials
Completed

NCT Number: NCT02025686

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

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.

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Key information

Conditions

Pain Burns Hyperalgesia Inflammation Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Normal ambient conditions

Other

Normal ambient conditions (1 ATA, FIO2 = 0.21)

Primary outcomes

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

    Time frame: 8 weeks

    Inflammation

Secondary outcomes

  1. Pain on Pain Scores on the Visual Analog Scale

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Per Rotbøll Nielsen

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 1, 2014
Registry last updated
Jan 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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