Complex Regional Pain Syndrome (CRPS) I & II Musculoskeletal Diseases Algoneurodystrophy
Conditions
Interventions
The test stimulation device will be implanted according to the guidelines of the Dutch Neuromodulation Society.
If patients report a 50% reduction of pain during the 1-2 weeks test pe
3: frequency 1200 Hz, and 4: Burst frequency) and placebo: no stimulation.
Every test period will last 2 weeks, and except for the first one will be preceded by a 1 week wash-out peri
Sponsors
Erasmus Medical Centre (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 2. Mean pain intensity of a least 5, measured on a Visual Analogue Scale 0-10 (VAS) 3. Duration of CRPS and pain longer than 12 months 4. No lasting success or too much complication with conventional therapy including medication, according to the Dutch CRPS Guideline
Exclusion criteria
Exclusion criteria: 1. Anticoagulant drug therapy or disturbed coagulation 2. Age < 18 years 3. Pregnancy 4. Implantable cardioverter defibrillators (ICD) and pacemaker 5. Life expectancy < 1 year 6. Lack of cooperation of the patient 7. Drugs/medication/alcohol addiction 8. Immune-compromised patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction/global perceived effect 2. Pain (VAS score) 3. McGill Pain Questionnaire DLV | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The medical history will include recording of CRPS specific items: 1.1. Hyperesthesia 1.2. Temperature asymmetry and/or skin colour changes and/or asymmetry 1.3. Oedema and/or sweating changes or sweating asymmetry 1.4. Dysfunction (weakness, tremor, dystonia) 2. Quantitative Sensory Testing will be performed | — |
Countries
Netherlands
Outcome results
None listed