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出境医 / 临床实验 / Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients

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

Study Description
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.

Condition or disease Intervention/treatment
Complex Regional Pain Syndromes Drug: Buprenorphine

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome(CRPS) Patients With Chronic Lower Back Pain: A Pilot Study
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
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 Name: norspan patch
Outcome Measures
Primary Outcome Measures :
  1. Changes in neuroinflammation [ Time Frame: baseline, 8 weeks ]
    [11C]-(R)-PK11195 PET distribution volume ratio (DVR)


Secondary Outcome Measures :
  1. Morphine equivalent [ Time Frame: baseline, 8 weeks ]
    narcotic analgesic dosage

  2. Physical test(1) [ Time Frame: baseline, 8 weeks ]
    blood test

  3. Physical test(2) [ Time Frame: baseline, 8 weeks ]
    urine test

  4. Physical test(3) [ Time Frame: baseline, 8 weeks ]
    Electrocardiogram(ECG) test (pulse rate)

  5. Physical test(4) [ Time Frame: baseline, 8 weeks ]
    pulse measurement

  6. Physical test(5) [ Time Frame: baseline, 8 weeks ]
    blood pressure measurement

  7. Self-reported questionnaire(1) [ Time Frame: baseline, 8 weeks ]
    Beck Depression Index(BDI)/ total score: 0~63, The higher the score, the more depressed

  8. Self-reported questionnaire(2) [ Time Frame: baseline, 8 weeks ]
    Beck Anxiety Index(BAI)/ total score: 0~63, The higher the score, the more anxiety

  9. 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

  10. Self-reported questionnaire(4) [ Time Frame: baseline, 8 weeks ]
    Pain Catastrophizing Scale/ total score: 0~52, The higher the score, the more pain Catastrophizing


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria)
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Soo-Hee Choi, MD,PhD +82 2-2072-2302 soohchoi@snu.ac.kr

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Jongno-gu, Korea, Republic of, 03080
Contact: Soo-Hee Choi, MD,PhD         
Sponsors and Collaborators
Seoul National University Hospital
Tracking Information
First Submitted Date May 23, 2019
First Posted Date June 6, 2019
Last Update Posted Date February 10, 2021
Actual Study Start Date June 11, 2019
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019) 		Changes in neuroinflammation [ Time Frame: baseline, 8 weeks ]
[11C]-(R)-PK11195 PET distribution volume ratio (DVR)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 5, 2019)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients
Official Title Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome(CRPS) Patients With Chronic Lower Back Pain: A Pilot Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria)
Condition Complex Regional Pain Syndromes
Intervention Drug: Buprenorphine
5~20 mcg
Other Name: norspan patch
Study Groups/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

Intervention: Drug: Buprenorphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 5, 2019) 		20
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2022
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Soo-Hee Choi, MD,PhD +82 2-2072-2302 soohchoi@snu.ac.kr
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03977012
Other Study ID Numbers NOR17-KR-IIT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Soo-Hee Choi, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Seoul National University Hospital
Verification Date February 2021

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