The objective of this study is to investigate if low frequency stimulation with a DRG stimulator effects peripheral blood blow in patients with CRPS and vasomotor disturbances. The secondary goal is to investigate if the frequency with the best…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the effect on peripheral blood flow.
Secondary outcome
The secondary parameters of this study are the mitoPO2 and mitoVO2.
Background summary
Complex regional pain syndrome (CRPS) is a complication after trauma or
surgery. CRPS is characterized by a continuing regional pain in a distal
extremity, often combined by vasomotor, sudomotor and motor/throphic
disturbances. In the chronic phase of CRPS the affected extremity can change
into a cold extremity induced by vasomotor disturbances that cause a decrease
in blood flow. Spinal cord stimulation (SCS) is effective on pain in CRPS.
Besides SCS also turns out to induce peripheral vasodilatation. However SCS has
also some limitations that were not found in Dorsal Root Ganglion (DRG)
stimulation. Clinical observations, however, show a positive effect on
vasomotor dysfunction of DRG stimulation in CRPS, at least in a part of the
patients. This effect seems to be frequency dependent. The pathophysiology of
vasomotore disturbances in CRPS is still not completely understood. Endothelial
dysfunction is one of the underlying mechanismes 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 in CRPS. The
COMET monitor assesses Cellular Oxygen METabolism by measuring cutaneous
mitoPO2 and mitoVO2 in humans.
Study objective
The objective of this study is to investigate if low frequency stimulation with
a DRG stimulator effects peripheral blood blow in patients with CRPS and
vasomotor disturbances. The secondary goal is to investigate if the frequency
with the best effect in peripheral blood flow also influences the mitoPO2 and
mitoVO2.
Study design
A prospective pilot study.
Intervention
Different frequencies of stimulation with a DRG Stimulator.
Study burden and risks
There may be a direct benefit from this intervention. If during the experiment
a frequency is found that gives a better effect for the patient than the
current settings, the settings of the DRG Stimulator will be adjusted. At the
long term this study may contribute to better treatment of vasomotor
disturbances in CRPS. There can be a burden for patients because setting off
the DRG-stimulator for a short period (30 minutes wash-out) and changes in the
stimulation frequency can temporarily and reversibly cause an increase in pain,
a change in skin temperature or skin color, or swelling in the affected
extremity due to changes of the settings of the DRG stimulator. The
intracellular oxygen measurement is a non-invasive measurement technique. The
specific discomfort for the subject is that aan aminolevulic acid
containers-plaster is applied that makes the skin sensitive for light. This
plaster is applied on the skin 5-8 hours before the measurement. The
measurement of mitoPO2 and mitoVO2 can may contribute to a better understanding
of the pathogenesis of vasomotor disturbances in CRPS.
Doctor Molenwaterplein 40
Rotterdam 3015 GD
NL
Doctor Molenwaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Patients diagnosed with CRPS according to the new IASP criteria
- Patients must have vasomotor disturbance; the skin temperature of the
affected extremity is at least 1°C colder than skin temperature of the
contralateral extremity. This will be measured using a thermography imaging
camera and determined using MatLab
- Patients must have a DRG stimulator for treatment of CRPS, that has been
implanted at least three months before inclusion
- Clinically the contralateral extremity must be without signs or symptoms in a
way that it can be used as a control.
Exclusion criteria
- Age < 18 years
- Patients diagnosed with other disease that influences the peripheral blood
flow
- Patients using medication that influences peripheral blood flow
- DRG stimulator implanted within three months before inclusion
NB: of patients suffer from mitochondrial disease or porphyria the measurement
of mitoPO2 and mitoVO2 will be leaved out.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67598.078.18 |
| OMON | NL-OMON27386 |