NCT05623579

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. 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 Oct 2023

Geographic Reach
1 country

2 active sites

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

October 25, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

October 25, 2022

Last Update Submit

November 29, 2023

Conditions

Chronic PainMusculoskeletal Pain

Keywords

BDNFPain Neuroscience EducationExercise

Outcome Measures

Primary Outcomes (1)

  • 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".

    36 weeks

Secondary Outcomes (7)

  • BDNF level

    36 weeks

  • Anxiety and Depression (HADS)

    36 weeks

  • Quality of life (EQ-5D)

    36 weeks

  • Pain Catastrophism (PCS)

    36 weeks

  • Pain Severity Level (GCPS-R)

    36 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Pain Education plus Exercise

Behavioral: Pain Neuroscience EducationBehavioral: Exercise

Control

ACTIVE COMPARATOR

Exercise

Behavioral: Exercise

Interventions

Pain Neuroscience EducationBEHAVIORAL

8 Sessions of different pain education interventions

Intervention
ExerciseBEHAVIORAL

12 Sessions of Aerobic Exercise

ControlIntervention

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
  • 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 (2)

Clínica URJC

Alcorcón, Madrid, 28922, Spain

NOT YET RECRUITING

IRF La Salle

Madrid, 28023, Spain

RECRUITING

Related Publications (2)

  • Mills SEE, Nicolson KP, Smith BH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br J Anaesth. 2019 Aug;123(2):e273-e283. doi: 10.1016/j.bja.2019.03.023. Epub 2019 May 10.

    PMID: 31079836BACKGROUND

  • Andias R, Neto M, Silva AG. The effects of pain neuroscience education and exercise on pain, muscle endurance, catastrophizing and anxiety in adolescents with chronic idiopathic neck pain: a school-based pilot, randomized and controlled study. Physiother Theory Pract. 2018 Sep;34(9):682-691. doi: 10.1080/09593985.2018.1423590. Epub 2018 Jan 10.

    PMID: 29319386RESULT

MeSH Terms

Conditions

Chronic PainMusculoskeletal PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

October 25, 2022

First Posted

November 21, 2022

Study Start

October 1, 2023

Primary Completion

December 30, 2024

Study Completion

May 28, 2025

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)