Reflex sympathetic dystrophy (RSD) related dystonia.
Conditions
Interventions
Screening phase:
To evaluate the efficacy of ITB a percutaneous catheter is introduced into the lumbar subarachnoid space.
All patients will start with a 2-day placebo run-in, followed by a gradual
visual analogue scale on which symptom severity is rated from 0 (absent) to 10 (most severe)) on ITB and placebo days.
This difference is calculated through the following steps:
1. GDSbaclo: for ea
2. GDShome: a similar mean sumscore of 6 1-hour intervals of the GDS at home is determined
3. For each day the GDS change score is calculated as follows:
GDSbaclo - GDShome = GDSchangescore1, expressed in % (calculated for each ITB day)
GDSplacebo - GDShome = GDSchangescore2, expressed in % (calculated for the mean of the 2 placebo days).
Criteria for being a candidate for pump implantation: a ≥
25% difference between the GDSchangescore1 and GDSchangescore2 present on 2 subsequent days (responder).
Implantat
Sponsors
Leiden University Medical Centre, Dept. of Neurology
Eligibility
Inclusion criteria
Inclusion criteria: 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): a. Continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event; b. Evidence at some time of edema, changes in skin blood flow, or abnormal sudomotor activity in the region of the pain; c. No condition that would otherwise account for the degree of pain and dysfunction; 2. All patients must suffer from tonic dystonia in 1 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.
Exclusion criteria
Exclusion criteria: N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. GDS will be calculated separately at baseline (GDShome) and during a week at 1 year of follow-up. The difference between these two measurements is identified as the change from baseline in GDS at 1-year follow-up (GDS1year); 2. Dystonia related functional limitations (DFL) are self-assessed at hourly intervals across the day using 4 items, addressing upper extremity function, capability of making transfers and mobility. Each item is assessed on a 0 – 3 scale. DFL will be calculated at baseline (DFLhome) and during a week at 1 year of follow-up. The difference between these 2 measurements is identified as the change from baseline in DFL at 1 year follow-up (DFL1year). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. RSD related impairments; 2. ADL and quality of life will be assessed separately before implantation and at 1-year follow-up; 3. The difference between these 2 measurements is identified as the change from baseline for each score. | — |
Contacts
Public ContactJ.J. Hilten, van
Leiden University Medical Center (LUMC), Department of Neurology, Postzone K-05Q, P.O. Box 9600
Outcome results
None listed