Intrathecal Baclofen Infusion for Reflex sympathetic Dystrophy related dystonia
- Conditions
- Signs and SymptomsPainReflex sympathetic dystrophy (RSD)
- Registration Number
- ISRCTN43633981
- Lead Sponsor
- eiden University Medical Centre (LUMC) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
1. All patients should fulfill the diagnostic criteria of the complex regional pain syndrome consensus report of the International Association for the Study of Pain (IASP):
1.1. Continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event
1.2. Evidence at some time of oedema, changes in skin blood flow, or abnormal sudomotor activity in the region of the pain
1.3. No condition that would otherwise account for the degree of pain and dysfunction
2. All patients must suffer from tonic dystonia in one or more extremities, that may cause fixed postures at rest of variable severity
3. Before starting the study all patients will have received a trial with oral baclofen. Only patients with an insufficient response or dose-limiting sedative effects to oral baclofen are eligible for this study
Does not comply with the above inclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. GDS will be calculated separately at baseline (GDShome) and during a week at one year of follow-up. The difference between these two measurements is identified as the change from baseline in GDS at one-year follow-up (GDS1year) <br>2. Dystonia related Functional Limitations (DFL) are self-assessed at hourly intervals across the day using four items, addressing upper extremity function, capability of making transfers and mobility. Each item is assessed on a zero to three scale. DFL will be calculated at baseline (DFLhome) and during a week at one year of follow-up.<br> <br>The difference between these two measurements is identified as the change from baseline in DFL at one year follow-up (DFL1year).
- Secondary Outcome Measures
Name Time Method 1. RSD related impairments<br>2. Activities of Daily Living (ADL) and quality of life will be assessed separately before implantation and at one-year follow-up<br><br>The difference between these two measurements is identified as the change from baseline for each score.