Complex Regional Pain Syndrome type 1
Conditions
Interventions
1. Before the start of the study all patients have received continuous ITB with a concentration of 3000 µg/ml.
The study starts with replacing the current substitution of 3000 µg/ml baclofen by rando
750 µg/ml ¨C 4-fold increase).
2. During a 2 week period, the first allocated flow rate will be used.
The following week, baclofen will be administered using the baseline flowrate in an unblinded
Sponsors
Leiden University Medical Center (LUMC), Department of Neurology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must suffer from tonic or intermittent dystonia in one or more extremities. 2. Patients have an implanted programmable pump (SynchroMed® pump, Medtronic, Minneapolis MN, USA, 40 mL reservoir) for continuous IT drug administration. 3. Patients have shown an insufficient response to ITB at the usual flow rate, that is a <25% improvement on dystonia severity while ITB was administered to a level of at least 1000 µg/day or lower because of dose-limiting side effects. 4. Patients must report spontaneous dystonia of at least 5 on a numeric rating scale (0 represents no dystonia, 10 represents worst imaginable dystonia).
Exclusion criteria
Exclusion criteria: N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of pain and dystonia using a NRS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy as evaluated by dystonia severity (Burke-Fahn-Marsden scale), patient¡¯s preference (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