ISRCTN38472359
Completed
Not Applicable
Treatment of Complex Regional Pain Syndrome type 1: a randomised, double-blind, placebo-controlled study with S(+)-ketamine
eiden University Medical Centre (Netherlands)0 sites60 target enrollmentJanuary 9, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eiden University Medical Centre (Netherlands)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be male or female adult patients with a clinical diagnosis of CRPS 1 who are referred to the pain centre outpatients' clinic of the department of Anaesthesiology at the LUMC.
- •1\. Patients should fulfill the diagnostic criteria of the consensus report of CRPS 1:
- •1\.1\. Continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event
- •1\.2\. Evidence at some time of edema, 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\. Patients must report a VAS\-spontaneous pain score of 5 cm or higher
- •3\. Patient's age is between 18 and 70 years
- •4\. Onset of symptoms must be shorter than 6 months or longer than 3 years before inclusion
- •5\. Patients should give a written informed consent
Exclusion Criteria
- •1\. Patients who are not able to give informed consent
- •2\. Patients suffering from other pain syndromes, interfering with pain ratings
- •3\. Patients suffering from other syndromes interfering with pain ratings
- •4\. Patients suffering from a kidney and/or severe liver disease
- •5\. Patients suffering from nerve damage in the affected area
- •6\. Patients with an active infection
- •7\. Patients with high intracranial pressure
- •8\. Patients with epilepsy
- •9\. Patients with a psychiatric illness
- •10\. Patients with thyroid disease
Outcomes
Primary Outcomes
Not specified
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