Chronic PainBDNFNCT05736575
Differences in Brain Derived Neurotrophic Factor Levels Between Chronic and Asymptomatic Pain Patients
An observational study of Chronic Pain, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
A case-control study will be conducted to analyze the differences in BDNF levels between patients with chronic pain and asymptomatic people. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- BDNF analysis (Elisa KIT)
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: subjects will be selected if they have been suffering from musculoskeletal pain (not oncological) for at least 3 months.
Who may be able to join
- 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.
Who cannot join
- Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Irf Cseuls
Madrid, 28053
Raul Ferrer, Physical Therapist, raul.ferrer@salud.madrid.org
About this study
A case-control study will be conducted to analyze the differences in BDNF levels between patients with chronic pain and asymptomatic people.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- BDNF analysis (Elisa KIT)
- Keywords
- BDNF
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDNF analysis (Elisa KIT)Genetic
Analysis of peripheral BDNF will be performed
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pain Patient | A blood draw is to be performed to analyze peripheral BDNF. Receives: Genetic: BDNF analysis (Elisa KIT) | |
| Asymptomatic subject | A blood draw is to be performed to analyze peripheral BDNF. Receives: Genetic: BDNF analysis (Elisa KIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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"
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 May 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Raúl Ferrer-Peña, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736575
- Sponsor's protocol ID
- CCBDNF
- Acronym
- BDNF
- Status last verified
- Nov 2023
- First submitted
- 9 Feb 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Brain Derived Neurotrophic Factor Levels Between Chronic and Asymptomatic Pain Patients
- ClinicalTrials.gov ID
- NCT05736575
- Acronym / sponsor ID
- BDNF / CCBDNF
- Conditions
- Chronic Pain
- Keywords
- BDNF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 15 May 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A case-control study will be conducted to analyze the differences in BDNF levels between patients with chronic pain and asymptomatic people.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain Patient | – | Genetic: BDNF analysis (Elisa KIT)A blood draw is to be performed to analyze peripheral BDNF. |
| Asymptomatic subject | – | Genetic: BDNF analysis (Elisa KIT)A blood draw is to be performed to analyze peripheral BDNF. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- subjects will be selected if they have been suffering from musculoskeletal pain (not oncological) for at least 3 months.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDNF analysis (Elisa KIT)Analysis of peripheral BDNF will be performed | Genetic | Asymptomatic subject, Chronic Pain Patient |
Primary outcome
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.
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"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raúl Ferrer, PhD (+34655412476, raul.ferrer@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF Levels (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.