Differences in Brain Derived Neurotrophic Factor Levels Between Chronic and Asymptomatic Pain Patients
BDNF
1 other identifier
observational
66
1 country
1
Brief Summary
A case-control study will be conducted to analyze the differences in BDNF levels between patients with chronic pain and asymptomatic people.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
May 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedNovember 30, 2023
November 1, 2023
10 months
February 9, 2023
November 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
BDNF Levels
Brain Derived Neurotrophic Factor: Pierce NeutrAvidin-coated high-capacity plates (ThermoFisher Scientific; 15509) will incubate for two hours at RT with 200 µl of 14 µg/ml biotin-conjugated mAb-#1 diluted in phosphate buffer (0.1% Triton X-100 in 0.1 M phosphate buffer: 0.1 M KH2PO4 and 0.1 M Na2HPO4; pH 7.6). Plates will then washed three times with blocking buffer \[1% bovine serum albumin (BSA); Sigma A2153 in phosphate buffer\], followed by the addition of 150 µl phosphate buffer. A total of 50 µl of either standards or diluted samples (both in blocking buffer) will then added to the plate followed by incubation for 3 h at RT on a rotary shaker.
3 hours
Pain Intensity
Pain intensity assessed with the 100 mm Visual Analog Scale, in which the patient is asked about his or her pain level at that moment, with one side being "no pain" and the other extreme being "the worst pain imaginable"
3 hours
Study Arms (2)
Chronic Pain Patient
A blood draw is to be performed to analyze peripheral BDNF.
Asymptomatic subject
A blood draw is to be performed to analyze peripheral BDNF.
Interventions
Analysis of peripheral BDNF will be performed
Eligibility Criteria
subjects will be selected if they have been suffering from musculoskeletal pain (not oncological) for at least 3 months.
You may qualify if:
- males and females aged 18 to 65 years with musculoskeletal pain for a minimum of 3 months
- patients recruited by information pamphlets from the university clinic of the Rey Juan Carlos University, and CSEU La Salle
- not having received physiotherapy treatment for this same process in the last 3 months.
- ability to perform all the clinical tests and to understand the study process, as well as to obtain informed consent.
You may not qualify if:
- Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Autonoma de Madridlead
- Universidad Rey Juan Carloscollaborator
Study Sites (1)
Irf Cseuls
Madrid, 28053, Spain
Biospecimen
BDNF levels will be measured through a blood sample taken by a nurse and analysed by a biochemist. Blood collection has been chosen over saliva analysis because the former has been shown to be the most reliable method for measuring this neurotrophin at the peripheral level.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2023
First Posted
February 21, 2023
Study Start
May 15, 2023
Primary Completion
February 28, 2024
Study Completion
December 30, 2024
Last Updated
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share