Back to resultsHyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)
Primary Purpose
Pain, Inflammation, Hyperalgesia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hyperbaric Oxygen
Normal ambient conditions
Sponsored by
About this trial
This is an interventional basic science trial for Pain focused on measuring Pain, Inflammation, Hyperalgesia, burn injury, Hyperbaric Oxygen
Eligibility Criteria
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
Sites / Locations
- Copenhagen University Hospital, Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperbaric Oxygen
Arm Description
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
Outcomes
Primary Outcome Measures
The effect of Hyperbaric Oxygen Therapy on Pain and Inflammation induced by Tonic Heat Stimulation in Human Volunteers
Inflammation
Secondary Outcome Measures
Pain on Pain Scores on the Visual Analog Scale
Full Information
NCT ID
NCT02025686
First Posted
December 9, 2013
Last Updated
December 30, 2013
Sponsor
Per Rotbøll Nielsen
1. Study Identification
Unique Protocol Identification Number
NCT02025686
Brief Title
Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)
Official Title
Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Per Rotbøll Nielsen
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inflammation, Hyperalgesia
Keywords
Pain, Inflammation, Hyperalgesia, burn injury, Hyperbaric Oxygen
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric Oxygen
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Hyperbaric Oxygen
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal ambient conditions
Intervention Description
Normal ambient conditions (1 ATA, FIO2 = 0.21)
Primary Outcome Measure Information:
Title
The effect of Hyperbaric Oxygen Therapy on Pain and Inflammation induced by Tonic Heat Stimulation in Human Volunteers
Description
Inflammation
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pain on Pain Scores on the Visual Analog Scale
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)
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