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Status unknownNCT05736575BDNFUpdated Nov 30, 2023

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

An observational study in Chronic Pain, sponsored by Universidad Autonoma de Madrid. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-11-30.

Sponsored by Universidad Autonoma de Madrid · Observational

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
66
Ages
18 Years to 65 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Chronic Pain

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Keywords

  • BDNF
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In context

Chronic Pain

2,999 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's planned enrollment of 66 is below the median of 128 across 706 observational studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Universidad Autonoma de Madrid is the lead sponsor of 51 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
66 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Chronic Pain Patient

    A blood draw is to be performed to analyze peripheral BDNF.

    Genetic: BDNF analysis (Elisa KIT)

  • Asymptomatic subject

    A blood draw is to be performed to analyze peripheral BDNF.

    Genetic: BDNF analysis (Elisa KIT)

Interventions

  • GeneticBDNF analysis (Elisa KIT)

    Analysis of peripheral BDNF will be performed

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 hours

  2. 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"

    Time frame: 3 hours

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Feb 2024, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2023
First posted
Feb 21, 2023
StartActual
May 15, 2023
Primary completionEst.
Feb 28, 2024
CompletionEst.
Dec 30, 2024
Last update
Nov 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05736575
Lead sponsor
Universidad Autonoma de Madrid
Responsible party
Raúl Ferrer-Peña (Principal Investigator, Universidad Autonoma de Madrid) — Principal investigator
First posted
Feb 21, 2023
Start date
May 15, 2023
Primary completion
Feb 28, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Nov 30, 2023

Study contacts

Raúl Ferrer, PhD
Contact
raul.ferrer@lasallecampus.es
+34655412476

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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