PainNCT03606915
Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease
An observational study of Pain, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- pain evaluation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 131 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jul 2015to 31 Dec 2019
- How long will I take part?
- 1 Day
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergo spinal anesthesia
Who may be able to join
- . Patients undergo spinal anesthesia
- . Over 20 years of age
- Patients who are competent to understand the study and provide written informed consent.
Who cannot join
- Patients have the contraindication for spinal anesthesia (refuse spinal anesthesia, coagulopathy, severe aortic stenosis)
- Refuse participated in this study or pre-existent neurological disease.
- Patients with advanced tumor staging (stage 3 or 4).
Trial locations and contacts
1 site in 1 country.
About this study
Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control.
Read the detailed description
The research protocol was approved by the Institutional Review Board (IRB) for the Protection of Human Subjects at National Cheng Kung University Hospital (NCKUH/B-ER-104-070). The study procedures were performed according to the rules of IRB and fully explained to the participants. Blood and CSF samples were collected and compared the difference in no pain group, acute pain group, and chronic pain group.
- Conditions
- Pain
- Being tested
- pain evaluation
- Keywords
- pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain evaluationBehavioural
collect CSF during spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| no pain | pain evaluation for patients performed surgery without painful condition (bleeding or others) Receives: Behavioral: pain evaluation | |
| acute pain | pain evaluation for patients performed surgery with painful condition within several days Receives: Behavioral: pain evaluation | |
| chronic pain | pain evaluation for patients performed surgery with the painful condition for over months Receives: Behavioral: pain evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine measurement in cerebrospinal fluid
cytokine measurement ( via ELISA) in cerebrospinal fluid
Measured: through study completion, an average of 1 year
cytokine measurement in blood
cytokine measurement (via ELISA) in blood
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start10 Jul 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen Chin Liu, National Cheng-Kung University Hospital
- Investigators
- Yen-Chin Liu, MD PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606915
- Sponsor's protocol ID
- B-ER-104-070
- Status last verified
- Feb 2020
- First submitted
- 15 Jun 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient privacy and no patient consent
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease
- ClinicalTrials.gov ID
- NCT03606915
- Acronym / sponsor ID
- B-ER-104-070
- Conditions
- Pain
- Keywords
- pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Jul 2018 (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.
Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control.
Detailed description
The research protocol was approved by the Institutional Review Board (IRB) for the Protection of Human Subjects at National Cheng Kung University Hospital (NCKUH/B-ER-104-070). The study procedures were performed according to the rules of IRB and fully explained to the participants. Blood and CSF samples were collected and compared the difference in no pain group, acute pain group, and chronic pain group.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no pain | – | Behavioral: pain evaluationpain evaluation for patients performed surgery without painful condition (bleeding or others) |
| acute pain | – | Behavioral: pain evaluationpain evaluation for patients performed surgery with painful condition within several days |
| chronic pain | – | Behavioral: pain evaluationpain evaluation for patients performed surgery with the painful condition for over months |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergo spinal anesthesia
Key inclusion criteria (3 listed)
- . Patients undergo spinal anesthesia
- . Over 20 years of age
Key exclusion criteria (3 listed)
- Patients have the contraindication for spinal anesthesia (refuse spinal anesthesia, coagulopathy, severe aortic stenosis)
- Refuse participated in this study or pre-existent neurological disease.
- Patients with advanced tumor staging (stage 3 or 4).
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 |
|---|---|---|
| pain evaluationcollect CSF during spinal anesthesia | Behavioural | acute pain, chronic pain, no pain |
Primary outcome
cytokine measurement in cerebrospinal fluid
Time frame: through study completion, an average of 1 year
cytokine measurement ( via ELISA) in cerebrospinal fluid
cytokine measurement in blood
Time frame: through study completion, an average of 1 year
cytokine measurement (via ELISA) in blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No. patient privacy and no patient consent
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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.
Yen-Chin Liu, MD PhD principal investigator
National Cheng Kung University
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 Pain, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Feb 2020. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine measurement in cerebrospinal fluid (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 26 Feb 2020.