Complex Regional Pain SyndromesNCT03977012
Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients
An observational study of Complex Regional Pain Syndromes, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Buprenorphine
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2019to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Soo-Hee Choi, MD,PhD
About this study
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
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
- Being tested
- Buprenorphine
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called norspan patch
5~20 mcg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neuroinflammation
[11C]-(R)-PK11195 PET distribution volume ratio (DVR)
Measured: baseline, 8 weeks
Secondary outcomes (10)
Morphine equivalent
narcotic analgesic dosage
Measured: baseline, 8 weeks
Physical test(1)
blood test
Measured: baseline, 8 weeks
Physical test(2)
urine test
Measured: baseline, 8 weeks
Physical test(3)
Electrocardiogram(ECG) test (pulse rate)
Measured: baseline, 8 weeks
Physical test(4)
pulse measurement
Measured: baseline, 8 weeks
Physical test(5)
blood pressure measurement
Measured: baseline, 8 weeks
Self-reported questionnaire(1)
Beck Depression Index(BDI)/ total score: 0~63, The higher the score, the more depressed
Measured: baseline, 8 weeks
Self-reported questionnaire(2)
Beck Anxiety Index(BAI)/ total score: 0~63, The higher the score, the more anxiety
Measured: baseline, 8 weeks
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
Measured: baseline, 8 weeks
Self-reported questionnaire(4)
Pain Catastrophizing Scale/ total score: 0~52, The higher the score, the more pain Catastrophizing
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start11 Jun 2019
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Hee Choi, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977012
- Sponsor's protocol ID
- NOR17-KR-IIT
- Status last verified
- Apr 2023
- First submitted
- 23 May 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03977012
- Acronym / sponsor ID
- NOR17-KR-IIT
- Conditions
- Complex Regional Pain Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CRPS Type I | – | Drug: BuprenorphinePatients 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 |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuprenorphineAlso: norspan patch5~20 mcg | Drug | Patients with CRPS Type I |
Primary outcome
Changes in neuroinflammation
Time frame: baseline, 8 weeks
[11C]-(R)-PK11195 PET distribution volume ratio (DVR)
10 secondary outcomes
Morphine equivalent
Time frame: baseline, 8 weeks
Physical test(1)
Time frame: baseline, 8 weeks
Physical test(2)
Time frame: baseline, 8 weeks
Physical test(3)
Time frame: baseline, 8 weeks
Physical test(4)
Time frame: baseline, 8 weeks
Physical test(5)
Time frame: baseline, 8 weeks
Self-reported questionnaire(1)
Time frame: baseline, 8 weeks
Self-reported questionnaire(2)
Time frame: baseline, 8 weeks
Self-reported questionnaire(3)
Time frame: baseline, 8 weeks
Self-reported questionnaire(4)
Time frame: baseline, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Complex Regional Pain Syndromes
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Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Regional Pain Syndromes, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo-Hee Choi, MD,PhD (+82 2-2072-2302, soohchoi@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neuroinflammation (time frame: baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.