Dystonia in complex regional pain syndrome type 1.
Conditions
Interventions
Intramuscular magnesiumsulphate:
1. Week 1: 500 mg twice a day
2. Week 2: 750 mg twice a day
3. Week 3: 1000 mg twice a day.
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must fulfill the diagnostic criteria of the 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 |
|---|---|
| Secondary outcomes are: 1. Efficacy as evaluated by pain and dystonia severity using NRS, McGill Pain Questionnaire, a device measuring the passive joint range of motion and muscle resistance to passive movement, patient’s preference questionnaire (PPQ), and global impression of improvement after each treatment (global impression scale); 2. Safety of the procedure as evaluated by the occurrence of adverse events. | — |
Contacts
Public ContactA.A. Plas, v.d
Neurology Resident & Clinical Research Fellow
Outcome results
None listed