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

Sponsor
Universidad Autonoma de Madrid (Other)
Overall Status
Recruiting
CT.gov ID
NCT05736575
Collaborator
Universidad Rey Juan Carlos (Other)
66
1
9.5
6.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
66 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Differences in Brain Derived Neurotrophic Factor Levels Between Chronic and Asymptomatic Pain Patients
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. BDNF Levels [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.

  2. Pain Intensity [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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Irf Cseuls Madrid Spain 28053

Sponsors and Collaborators

  • Universidad Autonoma de Madrid
  • Universidad Rey Juan Carlos

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raúl Ferrer-Peña, Principal Investigator, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier:
NCT05736575
Other Study ID Numbers:
  • CCBDNF
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Raúl Ferrer-Peña, Principal Investigator, Universidad Autonoma de Madrid
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023