dystonia of enlarged muscle tone
Conditions
Interventions
Intramuscular treatment with magnesiumsulphate or placebo (NaCl 0,9%).
Administration will start with a dose of 500 mg, two times a day, and raised to
a maximum of 750 mg, three times a day or 1000
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients must fulfill the diagnostic criteria of the IASP consensus report of CRPS I: a) continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event, and b) evidence at some time of edema, changes in skin blood flow or abnormal sudomotor activity in the region of the pain, and c) no condition that would otherwise account for the degree of pain and dysfunction;2. Patients must suffer from clinically significant tonic or intermittent dystonia in one or more extremities.;3. Patients must have symptoms for at least 1 year.
Exclusion criteria
Exclusion criteria: 1. Patients are excluded if they can obtain satisfactory relief of symptoms with conventional treatments. 2. Patients with a history of alcohol or drugs abuse within the past year. 3. Patients with clinically significant psychiatric illness. 4. Pregnant, nursing women and females of childbearing potential not using effective contraception. 5. Patients who are unlikely to comply with study requirements or have a history of poor compliance to medical regimens or study requirements. 6. Patients with an insufficient command and understanding of the Dutch language. 7. Patients involved in legal proceedings (claiming compensation for their CRPS I). 8. Patients with impaired coagulation. 9. Patients with impaired renal function (i.e. serum creatinine below 10 or exceeding 80 µmol/l). 10. Patients with hypermagnesaemia (i.e. total serum Mg exceeding 1.10 mmol/l). 11. Patients requiring the use of diuretics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is severity of dystonia using the Burke-Fahn-Marsden scale | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity of pain and dystonia using a NRS. 2. Severity of pain using the McGill Pain Questionnaire. 3. Assessment of the severity of dystonia using a device measuring the passive joint range of motion, and muscle resistance to passive movement. 4. Patient Preference Questionnaire. 5. The global impression scale. 6. Safety of the procedure as evaluated by the occurence of adverse events. | — |
Countries
Netherlands
Outcome results
None listed