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

Complex Regional Pain Syndromes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03977012
• Other study ID #: NOR17-KR-IIT
• Status: Recruiting
• Start date: June 11, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: Soo-Hee Choi, MD,PhD
• Phone: +82 2-2072-2302
• Email: soohchoi[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Buprenorphine
5~20 mcg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in neuroinflammation	[11C]-(R)-PK11195 PET distribution volume ratio (DVR)	baseline, 8 weeks
Secondary	Morphine equivalent	narcotic analgesic dosage	baseline, 8 weeks
Secondary	Physical test(1)	blood test	baseline, 8 weeks
Secondary	Physical test(2)	urine test	baseline, 8 weeks
Secondary	Physical test(3)	Electrocardiogram(ECG) test (pulse rate)	baseline, 8 weeks
Secondary	Physical test(4)	pulse measurement	baseline, 8 weeks
Secondary	Physical test(5)	blood pressure measurement	baseline, 8 weeks
Secondary	Self-reported questionnaire(1)	Beck Depression Index(BDI)/ total score: 0~63, The higher the score, the more depressed	baseline, 8 weeks
Secondary	Self-reported questionnaire(2)	Beck Anxiety Index(BAI)/ total score: 0~63, The higher the score, the more anxiety	baseline, 8 weeks
Secondary	Self-reported questionnaire(3)	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
Secondary	Self-reported questionnaire(4)	Pain Catastrophizing Scale/ total score: 0~52, The higher the score, the more pain Catastrophizing	baseline, 8 weeks