Differences in Brain Derived Neurotrophic Factor Levels Between Chronic and Asymptomatic Pain Patients (BDNF)

A case-control study will be conducted to analyze the differences in BDNF levels between patients with chronic pain and asymptomatic people.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Genetic: BDNF analysis (Elisa KIT)

Detailed Description

Brain-derived neurotrophic factor (BDNF) is considered a biomarker of brain plasticity. Since different alterations in brain plasticity have been found in chronic pain patients, the investigators want to study whether there are differences at the molecular level in this population compared to an asymptomatic population in order to be able to accurately measure the impact of different physiotherapy interventions in an objective way.

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Raúl Ferrer, PhD; Phone Number: +34655412476; Email: raul.ferrer@lasallecampus.es

Study Locations

• Spain
  • Madrid, Spain, 28053
    • Recruiting
    • Irf Cseuls
    • Contact: Raul Ferrer, Physical Therapist; Email: raul.ferrer@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

subjects will be selected if they have been suffering from musculoskeletal pain (not oncological) for at least 3 months.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Pain Patient; A blood draw is to be performed to analyze peripheral BDNF.	Genetic: BDNF analysis (Elisa KIT); Analysis of peripheral BDNF will be performed
Asymptomatic subject; A blood draw is to be performed to analyze peripheral BDNF.	Genetic: BDNF analysis (Elisa KIT); Analysis of peripheral BDNF will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid
• Collaborators: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 18, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: BDNF
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CCBDNF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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