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CompletedNCT02025686Updated Jan 1, 2014

Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)

An interventional study of Hyperbaric Oxygen and Normal ambient conditions in Pain, Inflammation and Hyperalgesia, sponsored by Per Rotbøll Nielsen. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-01.

Sponsored by Per Rotbøll Nielsen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Pain
  • Inflammation
  • Hyperalgesia

Keywords

  • Pain
  • Inflammation
  • Hyperalgesia
  • burn injury
  • Hyperbaric Oxygen
03

In context

Hyperalgesia

152 studies on the registry are indexed under Hyperalgesia; 13 are open to participants now.

This study's enrollment of 16 is below the median of 42 across 127 interventional studies indexed under Hyperalgesia.

Browse Hyperalgesia studies →

Lead sponsor

This is the only study on the registry with Per Rotbøll Nielsen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age > 18 yr Approved physical health examination Healthy Male

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Hyperbaric Oxygen

    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

    Drug: Hyperbaric Oxygen · Other: Normal ambient conditions

Interventions

  • DrugHyperbaric Oxygen

    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.

  • OtherNormal ambient conditions

    Normal ambient conditions (1 ATA, FIO2 = 0.21)

06

What researchers measure

Primary outcomes

  1. The effect of Hyperbaric Oxygen Therapy on Pain and Inflammation induced by Tonic Heat Stimulation in Human Volunteers

    Inflammation

    Time frame: 8 weeks

Secondary outcomes

  1. Pain on Pain Scores on the Visual Analog Scale

    Time frame: 8 weeks

07

Study locations

1 site
  • Copenhagen University Hospital, Rigshospitalet
    Copenhagen, 2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02025686
Lead sponsor
Per Rotbøll Nielsen
Responsible party
Per Rotbøll Nielsen (Consultant, Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Jan 1, 2014
Start date
Mar 2012
Primary completion
Aug 2012
Completion
Oct 2012
Last update
Jan 1, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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