NCT05736575

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

February 9, 2023

Last Update Submit

November 29, 2023

Conditions

Keywords

BDNF

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

Analysis of peripheral BDNF will be performed

Asymptomatic subjectChronic Pain Patient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects will be selected if they have been suffering from musculoskeletal pain (not oncological) for at least 3 months.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irf Cseuls

Madrid, 28053, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

BDNF levels will be measured through a blood sample taken by a nurse and analysed by a biochemist. Blood collection has been chosen over saliva analysis because the former has been shown to be the most reliable method for measuring this neurotrophin at the peripheral level.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

May 15, 2023

Primary Completion

February 28, 2024

Study Completion

December 30, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations