Patients with Complex Regional Pain Syndrome
Conditions
Interventions
Intravenous regional sympathetic nerve block with low-dose infliximab
Sponsors
Fukuoka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In-patient aged over 20 years old of Department Anesthesiology in Fukuoka University Hospital 2. Patients meet the diagnostic criteria for CRPS proposed by a working group in Ministry of Health, Labour, and Welfare. 3. Edema of diseased limb 4. Patients have unilateral diseased limb. 5. Patients meet all screening criteria for tuberculosis. No past history of latent or active tuberculosis No sign and symptom of active tuberculosis Negative results of T-spot or TB skin test No sign of active or old tuberculosis on Chest X-ray 6. Patients meet screening criteria for hepatitis. Negative HCV antibody, HBs antigen or HBc antibody test (HBV DNA not detected).
Exclusion criteria
Exclusion criteria: 1. The following laboratory data Hb<8.5g/microliter WBC<3.5*1000cells/microliter Neutrophil<1.0*1000cells/microliter PLT<5*10000cells/microliter ALT or AST>1.5*ULN Total Bilirubin>ULN Cr>=2.0mg/dL (NT-pro BNP>=125pg/ml) 2. Patients have severe, progressive or uncontrolled kidney disease, liver disease, skin disease, blood disease, digestive disease, endocrine disease, lung disease, cardiac disease, or neurological disease. 3. Patients had been hospitalized within 3 months for cardiac event(myocardial infarction or unstable angina), stroke or TIA. 4. Patients had severe infection within 2 months. 5. Patients have congestive heart failure in NYHA class 2 to 4. 6. Patients had relapse or progressive infectious disease including chronic renal infection, chronic chest infectious disease or urinary tract infection. Patients have past history of open drainage wound or ulcer. 7. Abnormal finding of interstitial pneumonia, tuberculosis, or other diseases on chest X-ray within 3 months 8. Past history of demyelinating disease including multiple sclerosis or optic neuritis 9. Patients have past history of gastrointestinal perforation or have active diverticulitis. 10. Patients had non-tuberculous mycobacterial infection or opportunistic infection within 6 months. 11. Hepatitis C positive 12. Hepatitis B positive 13. Patients have malignant neoplasm or had it within 5 years 14. Pregnant or lactating mother 15. Patients have steroid medication. 16. Investigator considers that the enrollment in this study is not benefit for the patient or intravenous regional sympathetic nerve blocking is impossible for the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Edema 2 Serum concentration of TNF-alpha 3 Allodynia 4 Skin color change 5 Skin temperature change | — |
Countries
Japan
Contacts
Public ContactShiho Shibata
Fukuoka University Hospital Department of Anesthesiology
Outcome results
None listed