Complex Regional Pain Syndromes
Conditions
Brief summary
In the present study, we aim to investigate the effect of buprenorphine on neuroinflammation in patients with complex regional pain syndrome, using \[11C\]-(R)-PK11195 PET.
Interventions
DRUGBuprenorphine
5\ 20 mcg
Sponsors
Seoul National University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria) and persistent back pain (VAS ≥ 4). 2. Patients who can stop benzodiazepine treatment 2 weeks before study 3. Patients who initially decided to use buprenorphine according to clinical judgment 4. Patients who are able to understand the purpose and procedure of the study
Exclusion criteria
1. Patients with an impaired cognitive function such as psychosis, dementia, or mental retardation 2. Patients with neurologic disease, cerebrovascular disease, history of brain tumor, history of severe head trauma, history of convulsive disease 3. Patients with cardiovascular disease, liver, respiratory or renal dysfunction 4. Patients with biliary disease 5. Patients who could not undergo the PET/magnetic resonance imaging (MRI) process. 6. Patients who have a risk of suicide or show aggressive behavior 7. Patients who have drug dependence (DSM-IV criteria) or history (past 6 months or older) 8. Employees of researchers or clinical research institutes 9. Patients with hypersensitivity or contraindication to buprenorphine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in neuroinflammation | baseline, 8 weeks | \[11C\]-(R)-PK11195 PET distribution volume ratio (DVR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical test(1) | baseline, 8 weeks | blood test |
| Physical test(2) | baseline, 8 weeks | urine test |
| Physical test(3) | baseline, 8 weeks | Electrocardiogram(ECG) test (pulse rate) |
| Physical test(4) | baseline, 8 weeks | pulse measurement |
| Morphine equivalent | baseline, 8 weeks | narcotic analgesic dosage |
| Self-reported questionnaire(1) | baseline, 8 weeks | Beck Depression Index(BDI)/ total score: 0\ 63, The higher the score, the more depressed |
| Self-reported questionnaire(2) | baseline, 8 weeks | Beck Anxiety Index(BAI)/ total score: 0\ 63, The higher the score, the more anxiety |
| Self-reported questionnaire(3) | baseline, 8 weeks | Short Form McGill Pain Questionnaire(SF-MPQ)/ 'a' subscale score: 0\ 45, The higher the score, the more painful/ 'b' subscale score, 0\ 10, The higher the score, the more painful/ 'c' subscale score, 0\ 5, The higher the score, the more painful |
| Self-reported questionnaire(4) | baseline, 8 weeks | Pain Catastrophizing Scale/ total score: 0\ 52, The higher the score, the more pain Catastrophizing |
| Physical test(5) | baseline, 8 weeks | blood pressure measurement |
Countries
South Korea
Contacts
Primary ContactSoo-Hee Choi, MD,PhD
Outcome results
None listed