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The Effect of Hyperbaric Oxygen Therapy on Inflammatory Parameters Induced by a Heat Injury Model (HBO-SHA)

Primary Purpose

Secondary Hyperalgesia, Inflammation

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Hyperbaric oxygen
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Secondary Hyperalgesia focused on measuring Reduction of secondary hyperalgesia and/-or local inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Session 1

Session 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Preconditioning
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.
Reduction in secondary hyperalgesia
Secondary hyperalgesia: PinPrick, 8 symmetrical lines converging towards the center of the heat injury with 45 degrees difference.

Secondary Outcome Measures

Pain reduction
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.

Full Information

First Posted
January 22, 2015
Last Updated
June 20, 2019
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02397343
Brief Title
The Effect of Hyperbaric Oxygen Therapy on Inflammatory Parameters Induced by a Heat Injury Model
Acronym
HBO-SHA
Official Title
The Effect of Hyperbaric Oxygen Therapy on Inflammatory Parameters Induced by a Heat Injury Model
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperalgesia, Inflammation
Keywords
Reduction of secondary hyperalgesia and/-or local inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Session 1
Arm Type
Other
Arm Description
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.
Arm Title
Session 2
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hyperbaric oxygen
Primary Outcome Measure Information:
Title
Preconditioning
Description
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.
Time Frame
4 weeks
Title
Reduction in secondary hyperalgesia
Description
Secondary hyperalgesia: PinPrick, 8 symmetrical lines converging towards the center of the heat injury with 45 degrees difference.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain reduction
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Hyldegaard, MD, Ph.D, DMSci
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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The Effect of Hyperbaric Oxygen Therapy on Inflammatory Parameters Induced by a Heat Injury Model

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