Complex Regional Pain Syndrome type 1 (CRPS I)
Conditions
Interventions
For future intrathecal baclofen treatment, in all patients a programmable pump for continuous intrathecal administration (SynchroMed® pump, Medtronic, Minneapolis MN, USA, 40 mL reservoir) and a lumba
Sponsors
Dept. of Neurology, Leiden University Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must fulfil 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; 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. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the safety of ITG. Safety evaluations include history taking, physical examination and neurological examination, blood and cerebrospinal fluid assessments and 12-lead electrocardiography (ECG). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is the efficacy of ITG compared to placebo. - Patients are assessed: 2 weeks before pump implantation, during both treatments at days 1, 8, 15, 22 and 29; - at days of dose adjustment, assessments are performed first. These assessments include: 1. Movement disorders assessments: A. Visual analogue (VAS) dystonia scale: self-assessed every monday at 9:00, 14:00 and 20:00 from 2 weeks before pump-implantation to the end of the study. Symptom severity is rated from 0 (absent) to 10 (most severe). B. Standardised measures are: - the Fahn-Marsden dystonia rating scale, - Barry-Albright Dystonia scale, - unified myoclonus rating scale (sections 2, 3, 4, 5, 7 and 8) and - tremor research group rating scale are assessed 2 weeks before pump implantation and during both treatments at days 1, 8, 15, 22 and 29. C. Change of dystonia is rated on a global impression scale. The blinded investigator assesses the change from baseline on a global impression scale at the end of both treatments. Sensory assessments: A. VAS pain scale: self-assessment (as VAS dystonia scale). B. McGill pain questionnaire: assessed every monday from 2 weeks before pump-implantation to the end of the study. C. Thermal sensory analyzer: to assess pain and temperature perception thresholds (Medoc Ltd, Israel, model TSA-II, using the method of limits) and is done during both treatments at days 1 and 29. A thermode is placed on the volar side of the wrists (if involved) and the dorsal side of the feet (if involved). Activity level: A. Radboud Skills Questionnaire: in case of involvement of upper extremities. B. Walking Ability Questionnaire: in case of involvement of lower extremities. | — |
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