Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients

Study Overview
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Brief Summary
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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.

Official Title
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Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome(CRPS) Patients With Chronic Lower Back Pain: A Pilot Study

Conditions
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Complex Regional Pain Syndromes

Intervention / Treatment
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* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria) and persistent back pain (VAS ≥ 4). Patients who can stop benzodiazepine treatment 2 weeks before study Patients who initially decided to use buprenorphine according to clinical judgment Patients who are able to understand the purpose and procedure of the study Exclusion Criteria: Patients with an impaired cognitive function such as psychosis, dementia, or mental retardation Patients with neurologic disease, cerebrovascular disease, history of brain tumor, history of severe head trauma, history of convulsive disease Patients with cardiovascular disease, liver, respiratory or renal dysfunction Patients with biliary disease Patients who could not undergo the PET/magnetic resonance imaging (MRI) process. Patients who have a risk of suicide or show aggressive behavior Patients who have drug dependence (DSM-IV criteria) or history (past 6 months or older) Employees of researchers or clinical research institutes Patients with hypersensitivity or contraindication to buprenorphine

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CRPS Type I<br>Patients diagnosed with Complex Regional Pain Syndrome Type I who are anticipated to recieve a 8 weeks regime of buprenorphine as a part of routine medical care. -drug name: norspan patch 5 20 mcg dosage form: patch frequency: every weeks duration: 8 weeks | Drug: Buprenorphine<br>* 5 20 mcg<br>* Other names: norspan patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in neuroinflammation | [11C]-(R)-PK11195 PET distribution volume ratio (DVR) | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine equivalent | narcotic analgesic dosage | baseline, 8 weeks | 
| Physical test(1) | blood test | baseline, 8 weeks | 
| Physical test(2) | urine test | baseline, 8 weeks | 
| Physical test(3) | Electrocardiogram(ECG) test (pulse rate) | baseline, 8 weeks | 
| Physical test(4) | pulse measurement | baseline, 8 weeks | 
| Physical test(5) | blood pressure measurement | baseline, 8 weeks | 
| Self-reported questionnaire(1) | Beck Depression Index(BDI)/ total score: 0 63, The higher the score, the more depressed | baseline, 8 weeks | 
| Self-reported questionnaire(2) | Beck Anxiety Index(BAI)/ total score: 0 63, The higher the score, the more anxiety | baseline, 8 weeks | 
| Self-reported questionnaire(3) | 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 | baseline, 8 weeks | 
| Self-reported questionnaire(4) | Pain Catastrophizing Scale/ total score: 0 52, The higher the score, the more pain Catastrophizing | baseline, 8 weeks |