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ID
Source
Brief title
Health condition
Complex Regional Pain Syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in skin temperature between the affected and contralateral extremity for each used frequency
Secondary outcome
Demographic variables
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 DRG stimulation. Clinical observations, however, show a positive effect on vasomotor dysfunction of Dorsal Root Ganglion (DRG) stimulation in CRPS, at least in a part of the patients. This effect seems to be frequency dependent.
The objective of this study is to investigate which frequencies of DRG stimulation have an influence on the peripheral blood flow of the affected extremity in patients with CRPS and vasomotor disturbances and should thereby be further investigated.
Study objective
Low frequency stimulation causes vasodilation in the affected extremity of patients with CRPS
Study design
Single measurement
Intervention
Different frequencies of stimulation with a DRG stimulator. The patients already have had a DRG stimulator surgically implanted as standard care for treatment of CRPS. The frequencies used as intervention in this experiment are in the range of standard treatment.
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8342 |
| CCMO | NL67598.078.18 |
| OMON | NL-OMON47944 |