Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease

Completed

• Conditions: Pain
• Interventions: Behavioral: pain evaluation

• Registration Number: NCT03606915
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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.

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 Timeline

• Study Start: 2015-07-10
• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-07-28
• Study First Posted: 2018-07-31
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• . Patients undergo spinal anesthesia

• . Over 20 years of age

  • Patients who are competent to understand the study and provide written informed consent.

Exclusion Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no pain	pain evaluation	pain evaluation for patients performed surgery without painful condition (bleeding or others)
acute pain	pain evaluation	pain evaluation for patients performed surgery with painful condition within several days
chronic pain	pain evaluation	pain evaluation for patients performed surgery with the painful condition for over months

Primary Outcome Measures

Name	Time	Method
cytokine measurement in cerebrospinal fluid	through study completion, an average of 1 year	cytokine measurement ( via ELISA) in cerebrospinal fluid
cytokine measurement in blood	through study completion, an average of 1 year	cytokine measurement (via ELISA) in blood

Trial Locations

Locations (1)

National Cheng Kung University; 🇨🇳 Tainan, Taiwan