The Effect of Hyperbaric Oxygen Therapy on Inflammatory Parameters Induced by a Heat Injury Model (HBO-SHA)
June 20, 2019 updated by: Ole Hyldegaard, Rigshospitalet, Denmark
Hyperbaric oxygen may reduce neurophatic pain and promote wound healing.
Established anti inflammatory effects of HBO may contribute to this effect.
In a previous publication the investigators studied the effects of HBO on secondary hyperalgesia using a well established heat injury model.
In a new - blinded study design, the investigators wish to investigate and- or confirm previous results, i.e. that HBO therapy reduce secondary hyperalgesia and improving therapy of severe pain conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hyperbaric oxygen (HBO) reduces neuropathic pain, promote healing of hypoxic, chronic wounds and sores caused by radiation therapy.
Nitric oxide (NO) is a contributing factor to the prolonged anti-nociceptive effect of HBO treatment.
In addition, HBO stimulates the formation of reactive oxygen and nitrogen forms, reduces beta-2 integrin function, and reduces contact of leukocytes to the endothelial surface of the capillaries, improves microcirculation and causes decreased monocyte chemokine synthesis.
It is the interaction of these mechanisms involved in HBO's anti-inflammatory effect.
How HBO reduces pain and inflammation in humans has not been established.
In healthy subjects, investigators have shown that HBO has a reducing effect on the mechanism, which at the level the of spinal cord amplifies the number and and the extension of pain impulses.
Subjects who were given HBO therapy initially developed significantly less secondary hyperalgesia than the control group several weeks later by the new heat injury suggesting a protective, preconditioning effect.
As in the previous experiment (NCT02025686) preconditioning effects will be assessed by means of measurements of thermal thresholds, pin-prick thresholds, erythema indices and secondary hyperalgesic areas (i.e.
area under the curve per minute).
Similarly,differences in the sequence of sessions (i.e.
first session HBO;second session ambient pressure condition or first session ambient pressure condition;second session HBO) will be analyzed accordingly.
In an improved blinded study design investigators will now investigate the effect of HBO treatment using the same cutaneous heat injury model, as in the first study.
Investigators expect to finally be able to confirm previous results thereby improving treatment of severe pain conditions.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Copenhagen Ø, Denmark, 2100
- Rigshospitalet
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male
- speaks and understands danish language
- understood and signed informed consent before medical examination
Exclusion Criteria:
- younger than 18 years of age
- hypertension
- not able to perform equalization of ears and sinuses
- persons who present with a medical history of previous pneumothorax and/- or who may be considered of increased risk of pneumothorax
- diabetics, epilepsia,asthma
- neurological deficits including cognitive as well as psychomotoric disorders
- claustrophobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Session 1
HBO given the first day of study period and sensory test battery performed.
4 weeks later no intervention is given but the sensory test battery performed.
|
|
|
Other: Session 2
No intervention first day of study period and sensory test battery performed.
4 weeks later HBO intervention is given and the sensory test battery performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preconditioning
Time Frame: 4 weeks
|
Erythema and edema: DermoLab Combo, Cortex Technology, Hadsund. Pain: Is measured at specific times while the heat injury is being made using a VAS scale from 0-10. Hyperalgesia: Weighted pins (PinPrick 8, 16, 32, 64, 128, 256, 512 mN) using Dixon's "up-and-down" method. Secondary hyperalgesia: PinPrick, 8 symmetrical lines converging towards the center of the heat injury with 45 degrees difference. All parameters are compared within the two sessions to assess preconditioning. |
4 weeks
|
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Reduction in secondary hyperalgesia
Time Frame: 4 weeks
|
Secondary hyperalgesia: PinPrick, 8 symmetrical lines converging towards the center of the heat injury with 45 degrees difference.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain reduction
Time Frame: 4 weeks
|
Pain: Is measured at specific times while the heat injury is being made using a VAS scale from 0-10. Hyperalgesia: Weighted pins (PinPrick 8, 16, 32, 64, 128, 256, 512 mN) using Dixon's "up-and-down" method. Secondary hyperalgesia: PinPrick, 8 symmetrical lines converging towards the center of the heat injury with 45 degrees difference. |
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ole Hyldegaard, MD, Ph.D, DMSci, Rigshospitalet, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
January 22, 2015
First Submitted That Met QC Criteria
March 23, 2015
First Posted (Estimate)
March 24, 2015
Study Record Updates
Last Update Posted (Actual)
June 21, 2019
Last Update Submitted That Met QC Criteria
June 20, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBO-SHA
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