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

Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: pain evaluation

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 Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • National Cheng Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergo spinal anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no pain; pain evaluation for patients performed surgery without painful condition (bleeding or others)	Behavioral: pain evaluation; collect CSF during spinal anesthesia
acute pain; pain evaluation for patients performed surgery with painful condition within several days	Behavioral: pain evaluation; collect CSF during spinal anesthesia
chronic pain; pain evaluation for patients performed surgery with the painful condition for over months	Behavioral: pain evaluation; collect CSF during spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cytokine measurement in cerebrospinal fluid	cytokine measurement ( via ELISA) in cerebrospinal fluid	through study completion, an average of 1 year
cytokine measurement in blood	cytokine measurement (via ELISA) in blood	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Yen-Chin Liu, MD PhD, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: July 28, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: pain
• Other Study ID Numbers: B-ER-104-070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: patient privacy and no patient consent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No