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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 29, 2020

Interventions

  • Drug: Buprenorphine
    • 5~20 mcg

Arms, Groups and Cohorts

  • Patients with CRPS Type I
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Changes in neuroinflammation
    • Time Frame: baseline, 8 weeks
    • [11C]-(R)-PK11195 PET distribution volume ratio (DVR)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soo-Hee Choi, Associate Professor – Seoul National University Hospital
  • Overall Contact(s)
    • Soo-Hee Choi, MD,PhD, +82 2-2072-2302, soohchoi@snu.ac.kr

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