The influence of different flow rates of intrathecal baclofen infusion on dystonia and pain in Complex Regional Pain Syndrome type 1
Recruiting
- Conditions
- Complex Regional Pain Syndrome type 1
- Registration Number
- NL-OMON20461
- Lead Sponsor
- eiden University Medical Center (LUMC), Department of Neurology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
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.
Exclusion Criteria
N/A
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of pain and dystonia using a NRS.
- Secondary Outcome Measures
Name Time Method 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). <br /><br>2. Safety of the procedure as evaluated by the occurrence of adverse events. <br>