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Trial record 4 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Reflex Sympathetic Dystrophy"

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

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ClinicalTrials.gov Identifier: NCT03977012
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Soo-Hee Choi, Seoul National University Hospital

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

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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 : August 8, 2019
Estimated Study Completion Date : April 30, 2020


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977012


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

Locations
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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

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Responsible Party: Soo-Hee Choi, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03977012     History of Changes
Other Study ID Numbers: NOR17-KR-IIT
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists