The primary objective is to investigate if there is altered mitochondrial oxygenation and consumption in the skin cells of the affected extremity in patients with CRPS by measuring the mitoPO2 and mitoVO2.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline mitoPO2 of the affected and contralateral extremity and MitoVO2 of the
affected and contralateral extremity.
Secondary outcome
• Demographic parameters such as: age, sex, smoking and consumption of alcohol
• General medical history and medication use
• CRPS severity score
• Videothermography image of the affected and contralateral extremity
Background summary
Complex regional pain syndrome (CRPS) is a complication after trauma or
surgery. CRPS is characterized by chronic pain in a distal extremity, usually
combined with abnormal sensory, autonomic, motor and/or trophic changes.
Temperature asymmetry is common in CRPS. The pathophysiology of vasomotor
disturbances in CRPS is still not completely understood. Endothelial
dysfunction is one of the underlying mechanisms of vasomotor disturbances in
CRPS. Mitochondrial dysfunction is associated with endothelial dysfunction in
cardiovascular diseases. It could be possible that mitochondrial dysfunction
also plays a role in the pathogenesis of vasomotor disturbances CRPS. The COMET
monitor assesses Cellular Oxygen METabolism by measuring cutaneous mitoPO2 and
mitoVO2 in humans.
Study objective
The primary objective is to investigate if there is altered mitochondrial
oxygenation and consumption in the skin cells of the affected extremity in
patients with CRPS by measuring the mitoPO2 and mitoVO2.
Study design
A single-center feasibility study in patients with CRPS.
Study burden and risks
The intracellular oxygen measurement is a non-invasive measurement technique.
The specific discomfort for the subject is that an aminolevulic acid
containing-plaster is applied that makes the skin sensitive for light. This
plaster is applied on the skin 5-8 hours before the measurement. The
participants will not benefit directly from participation of the study. It
takes patients about half an hour of time. This study can may contribute to a
better understanding of the pathogenesis of vasomotor disturbances in CRPS. The
risk in this study is negligible. Thereby the group related benefits
counterweight the risks in this study.
Doctor Molenwaterplein 40
Rotterdam 3015 GD
NL
Doctor Molenwaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Diagnosed with CRPS according to the new IASP criteria. We will only include
patients that still meet these criteria.
• Clinically the contralateral extremity must be without signs or symptoms in a
way that it can be used as a control
• Signed informed consent
Exclusion criteria
• < 18 years of age
• Presence of mitochondrial disease
• Porphyria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68809.078.19 |