Complex Regional Pain Syndrome type 1 (CRPS I) Signs and Symptoms Pain syndrome
Conditions
Interventions
Intervention: 70 mg/kg magnesium sulphate continuously administered in four hours via an intravenous infusion (in two 50 ml syringe) of 24 ml/hour a day for a period of five days
Contr
Sponsors
Vrije University Medical Centre (VUMC) (The Netherlands)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnostic criteria for Complex Regional Pain Syndrome type one (CRPS1) according to the International Association for the Study of Pain (IASP): a. presence of an initiating noxious event or cause for immobilisation b. continuing pain, allodynia or hyperalgesia, with which the pain is disproportioned to any inciting event and is not limited to the area of an individual peripheral nerve c. evidence at any time of oedema. Skin blood flow abnormality, or abnormal sudomotor activity in the painful area since the inciting event d. conditions which could otherwise account for the level of pain and dysfunction should be excluded Note: criteria b-d have to be met 2. A Visual Analogue Scale (VAS)-spontaneous pain score of 5 cm or higher 3. Patients should be between 18 to 70 years old 4. CRPS1 in one extremity 5. First time experience of patient with CRPS1 6. Other medication has to be stopped for more then one week before the trial starts 7. Patients should give written informed consent
Exclusion criteria
Exclusion criteria: 1. Not being able to give informed consent 2. Another (second) chronic pain syndrome, interfering with pain ratings 3. Another syndrome interfering with functional tests 4. CRPS1 in both hands or feet 5. Patient has experienced CRPS1 before 6. Known kidney and/or severe liver disease 7. Known nerve damage in the affected area 8. Active infection 9. Mental retardation 10. Psychiatric abnormality 11. Malignant disease 12. Patients with heart failure 13. Patients with pacemakers or implanted defibrillators 14. Patients with pulmonary congestion 15. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain will be measured in a pain diary at baseline, 1, 3, 6 and 12 weeks after treatment. In this diary patients will record their pain rate on a 11 point Box scale three times daily for a period of one week before each measurement point. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensory complaints: a. McGill pain questionnaire will be used to obtain information about the type of pain experienced by patients b. Semmes Weinstein Monofilaments will be used to objectively measure sensitivity of the skin (e.g. hypesthesia, hyperesthesia and allodynia) 2. Impairments: patients functional status will be assessed with the Impairment Level Sumscore, in which: pain (measured by Box scale and McGill pain questionnaire), temperature (measured with infrared thermometer), volume (measured with water displacement volumeter) and active range of motion (measured with goniometers) will be converted into a compound sumscore 3. Functional disability: the Radboud Skills Questionnaire, the Walking Stairs Questionnaire and Questionnaire Rising and Sitting Down will be used to assess disability in patients with respectively upper and lower CRPS1 4. Quality of life: The 36-item Short Form (SF-36) and European Quality of Life (EuroQol) questionnaires will be used to measure quality of life Secondary outcomes will be measured at baseline, 1, 3, 6 and 12 weeks after treatment. | — |
Countries
Netherlands
Outcome results
None listed