Treatment of Complex Regional Pain Syndrome type 1: a randomised, double-blind, placebo-controlled study with S(+)-ketamine

Completed

• Conditions: Complex regional pain syndrome type 1 (CRPS I); Musculoskeletal Diseases; Other disorders of bone

• Registration Number: ISRCTN38472359
• Lead Sponsor: eiden University Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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
11. Patients with cancer
12. Patients with cardiac disease
13. Patients with pulmonary disease
14. Patients with glaucoma
15. Patients with a history of cerebral vascular accident (CVA)
16. Patients who are a pregnant
17. Strong-opioid consumption (step one and two of the WHO pain ladder is allowed)

Study & Design

• Study Type: Interventional
• Study Design: Not specified