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

Inflammation Clinical Trial

— HBO-SHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397343
• Other study ID #: HBO-SHA
• Status: Completed
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperalgesia
• Inflammation
• Secondary Hyperalgesia

Intervention

Drug:
• Hyperbaric oxygen

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen Ø

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	Reduction in secondary hyperalgesia	Secondary hyperalgesia: PinPrick, 8 symmetrical lines converging towards the center of the heat injury with 45 degrees difference.	4 weeks
Secondary	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.	4 weeks