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

November 29, 2023 updated by: Raúl Ferrer-Peña, Universidad Autonoma de Madrid
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 3 hours
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
Time Frame: 3 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Madrid

Collaborators

Universidad Rey Juan Carlos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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