- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05736575
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
- Name: Raúl Ferrer, PhD
- Phone Number: +34655412476
- Email: raul.ferrer@lasallecampus.es
Study Locations
-
-
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Madrid, Spain, 28053
- Recruiting
- Irf Cseuls
-
Contact:
- Raul Ferrer, Physical Therapist
- Email: raul.ferrer@salud.madrid.org
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-
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.
|
Analysis of peripheral BDNF will be performed
|
Asymptomatic subject
A blood draw is to be performed to analyze peripheral BDNF.
|
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
Collaborators
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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