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

NCT02397343 | Completed Phase 2 DMC

• 1 other identifier: HBO-SHA
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Hyperalgesia; Inflammation

Keywords

Reduction of secondary hyperalgesia and/-or local inflammation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Pain reduction

  4 weeks

Study Arms (2)

Session 1

OTHER

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.

Drug: Hyperbaric oxygen

Session 2

OTHER

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.

Drug: Hyperbaric oxygen

Interventions

Hyperbaric oxygen DRUG

Session 1; Session 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male
• speaks and understands danish language
• understood and signed informed consent before medical examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Hyperalgesia; Inflammation

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Ole Hyldegaard, MD, Ph.D, DMSci

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Ass.prof

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: March 24, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 21, 2019

Record last verified: 2019-06

Locations

DK (1)