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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05736575
Other study ID # CCBDNF
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date December 30, 2024

Study information

Verified date November 2023
Source Universidad Autonoma de Madrid
Contact Raúl Ferrer, PhD
Phone +34655412476
Email raul.ferrer@lasallecampus.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 30, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Genetic:
BDNF analysis (Elisa KIT)
Analysis of peripheral BDNF will be performed

Locations

Country Name City State
Spain Irf Cseuls Madrid

Sponsors (2)

Lead Sponsor Collaborator
Universidad Autonoma de Madrid Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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