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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02397343
Other study ID # HBO-SHA
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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