NCT05736172

Brief Summary

The promotion of neuroplasticity in conjunction with strategies for restructuring maladaptive cognitions that largely cause the activation of neural networks that contribute to the perpetuation of pain is therefore a fundamental neurophysiological principle for establishing a neurophysiological basis for pain. perpetuation of pain, is therefore a fundamental neurophysiological principle for establishing physiotherapy therapeutic to establish therapeutic strategies from physiotherapy that contribute to improve the quality of life of patients with chronic pain. Based on the theory that neurotrophic factors such as BDNF play a fundamental role in the initiation and or maintenance of hyperexcitability of central neurons in pain, we consider that the levels of this neurotrophic factor, such as BDNF, may have an important role in the perpetuation of pain. That the levels of this neurotrophic factor may be modified by the application of a therapeutic education protocol, favoring therapeutic education protocol, favoring a reduction in pain intensity.

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 P50-P75 for not_applicable chronic-pain

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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

February 9, 2023

Last Update Submit

November 29, 2023

Conditions

Chronic PainMusculoskeletal Pain

Keywords

bdnfpain neuroscience education

Outcome Measures

Primary Outcomes (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".

    three hours

  • BDNF level

    BDNF level measured in blood serum by ELISA kit at baseline and at the end of the intervention.

    three hours

Secondary Outcomes (4)

  • Anxiety and Depression (HADS)

    3 hours

  • Quality of life (EQ-5D)

    3 hours

  • Pain Catastrophism Scale (PCS)

    3 hours

  • Pain Severity Level (GCPS-R)

    3 hours

Study Arms (2)

Pain group education

EXPERIMENTAL

In this group, the education session will be provided in a face-to-face group setting.

Behavioral: Pain neuroscience grupal education

Pain material education

ACTIVE COMPARATOR

In this group the same education session will be provided in written form by means of a leaflet.

Behavioral: Pain neuroscience grupal education

Interventions

Pain neuroscience grupal educationBEHAVIORAL

The face to face education group will be carried out with a physiotherapist addressing various topics in the neurosciences of pain. In the active control group, information will only be provided in written form for the individual patient to read.

Also known as: Pain neuroscience written education
Pain group educationPain material education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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)

Silvia Di Bonaventura

Madrid, 28008, Spain

RECRUITING

MeSH Terms

Conditions

Chronic PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Silvia Di Bonaventura

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
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

May 30, 2024

Study Completion

November 30, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)