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

April 13, 2023 updated by: Soo-Hee Choi, Seoul National University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
5~20 mcg
Other Names:
  • norspan patch

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in neuroinflammation
Time Frame: baseline, 8 weeks
[11C]-(R)-PK11195 PET distribution volume ratio (DVR)
baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Morphine equivalent
Time Frame: baseline, 8 weeks
narcotic analgesic dosage
baseline, 8 weeks
Physical test(1)
Time Frame: baseline, 8 weeks
blood test
baseline, 8 weeks
Physical test(2)
Time Frame: baseline, 8 weeks
urine test
baseline, 8 weeks
Physical test(3)
Time Frame: baseline, 8 weeks
Electrocardiogram(ECG) test (pulse rate)
baseline, 8 weeks
Physical test(4)
Time Frame: baseline, 8 weeks
pulse measurement
baseline, 8 weeks
Physical test(5)
Time Frame: baseline, 8 weeks
blood pressure measurement
baseline, 8 weeks
Self-reported questionnaire(1)
Time Frame: baseline, 8 weeks
Beck Depression Index(BDI)/ total score: 0~63, The higher the score, the more depressed
baseline, 8 weeks
Self-reported questionnaire(2)
Time Frame: baseline, 8 weeks
Beck Anxiety Index(BAI)/ total score: 0~63, The higher the score, the more anxiety
baseline, 8 weeks
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
baseline, 8 weeks
Self-reported questionnaire(4)
Time Frame: baseline, 8 weeks
Pain Catastrophizing Scale/ total score: 0~52, The higher the score, the more pain Catastrophizing
baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NOR17-KR-IIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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