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

NCT03977012 | Unknown

• 1 other identifier: NOR17-KR-IIT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (1)

• Changes in neuroinflammation

  \[11C\]-(R)-PK11195 PET distribution volume ratio (DVR)

  baseline, 8 weeks

Secondary Outcomes (10)

• Morphine equivalent

  baseline, 8 weeks

• Physical test(1)

  baseline, 8 weeks

• Physical test(2)

  baseline, 8 weeks

• Physical test(3)

  baseline, 8 weeks

• Physical test(4)

  baseline, 8 weeks

Study Arms (1)

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

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

5\~20 mcg

Also known as: norspan patch

Patients with CRPS Type I

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Soo-Hee Choi, MD,PhD

CONTACT

+82 2-2072-2302; soohchoi@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 6, 2019
• Study Start: June 11, 2019
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)