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Esercizio, PNE e allenamento cognitivo in individui con lombalgia cronica

18 settembre 2026 aggiornato da: Ellen Hirose Pereira Nery, Aveiro University

Educazione alle neuroscienze del dolore, esercizio fisico e formazione cognitiva negli individui con lombalgia cronica idiopatica: uno studio randomizzato a tre bracci

This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education (PNE) will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).

It will have three arms of which will receive exercise, PNE and/or cognitive training for 8 weeks (Group I - exercise and PNE; Group II - exercise, PNE and cognitive training; Group III - cognitive training).

Participants will be assessed for pain characteristics, psychological, and cognitive aspects at baseline, post-intervention and at 3 months follow-up.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

99

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Portogallo
    • Aveiro District
      • Aveiro, Aveiro District, Portogallo
        • University of Aveiro

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 64 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • have chronic idiopathic LBP
  • report pain intensity of at least 2 out of 10 on the Numeric Pain Rating Scale
  • 18 to 64 years old
  • Be able to read, write and speak Portuguese
  • Asses to personal computer and internet for those receiving cognitive training

Exclusion Criteria:

  • individuals receiving any chronic treatment for their pain
  • symptoms of peripheral nervous system pathology (e.g., motor weakness and sensory disturbance);
  • a diagnosis of an ongoing neurological disease with peripheral or central nervous system involvement or relevant sequela;
  • having a diagnosis of ongoing psychiatric disease
  • having relevant cognitive impairment as assessed by Montreal Cognitive Assessment (MoCA).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention 1

Participants will receive exercise, PNE and online cognitive training sessions.
Altro: Experimental

Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
Comparatore attivo: Intervention 2

Participants will receive exercise and pain neuroscience education (PNE).
Altro: Exercise and PNE

Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
Comparatore attivo: Intervention 3

Participants will receive online cognitive training sessions.
Altro: Cognitive training

Online sessions of cognitive training.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numeric Pain Rating Scale Numeric Pain Rating Scale
Lasso di tempo: baseline

Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
baseline
Numeric Pain Rating Scale Numeric Pain Rating Scale
Lasso di tempo: post-intervention - 8 weeks

Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
post-intervention - 8 weeks
Numeric Pain Rating Scale Numeric Pain Rating Scale
Lasso di tempo: 3 months follow-up

Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
3 months follow-up

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cognitive Function
Lasso di tempo: baseline

Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance.
baseline
Cognitive Function
Lasso di tempo: post-intervention - 8 weeks

Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance.
post-intervention - 8 weeks
Cognitive Function
Lasso di tempo: 3 months follow-up.

Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance.
3 months follow-up.
Roland Morris disability questionnaire
Lasso di tempo: baseline

The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability.
baseline
Roland Morris disability questionnaire
Lasso di tempo: post-intervention - 8 weeks

The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability.
post-intervention - 8 weeks
Roland Morris disability questionnaire
Lasso di tempo: 3 months follow-up

The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability.
3 months follow-up
Central sensitization Inventory
Lasso di tempo: baseline

The central sensitization inventory (CSI) assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points.
baseline
Central sensitization Inventory
Lasso di tempo: post-intervention - 8 weeks

The central sensitization inventory (CSI) assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points.
post-intervention - 8 weeks
Central sensitization Inventory
Lasso di tempo: 3 months follow-up

The central sensitization inventory (CSI)assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points.
3 months follow-up
Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: baseline

HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression.
baseline
Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: post-intervention - 8 weeks

HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression.
post-intervention - 8 weeks
Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: 3 months follow-up.

HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression.
3 months follow-up.
TAMPA Scale of Kinesiophobia
Lasso di tempo: baseline

The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement.
baseline
TAMPA Scale of Kinesiophobia
Lasso di tempo: post-intervention - 8 weeks

The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement.
post-intervention - 8 weeks
TAMPA Scale of Kinesiophobia
Lasso di tempo: 3 months follow-up.

The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement.
3 months follow-up.
Pain Catastrophizing Scale
Lasso di tempo: Baseline

The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing.
Baseline
Pain Catastrophizing Scale
Lasso di tempo: post-intervention - 8 weeks

The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing.
post-intervention - 8 weeks
Pain Catastrophizing Scale
Lasso di tempo: 3 months follow-up.

The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing.
3 months follow-up.
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
Lasso di tempo: baseline

The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep.
baseline
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
Lasso di tempo: post-intervention - 8 weeks

The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep.
post-intervention - 8 weeks
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
Lasso di tempo: 3 months follow-up.

The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep.
3 months follow-up.
Two-point discrimination
Lasso di tempo: baseline

Two-point discrimination is used to assess cortical reorganization.
baseline
Two-point discrimination
Lasso di tempo: post-intervention - 8 weeks

Two-point discrimination is used to assess cortical reorganization.
post-intervention - 8 weeks
Two-point discrimination
Lasso di tempo: 3 months follow-up

Two-point discrimination is used to assess cortical reorganization.
3 months follow-up
Patient's Global Impression of Change (PGIC)
Lasso di tempo: post-intervention - 8 weeks

PGIC evaluates the perception of improvement associated with the intervention. Participants are instructed to select on a scale from 1 ("No change or condition worsened") to 7 ("Much better, and with a considerable improvement that made all the difference") the statement that best reflected the impact of the intervention on their condition.
post-intervention - 8 weeks
Patient's Global Impression of Change (PGIC)
Lasso di tempo: 3 months follow-up.

PGIC evaluates the perception of improvement associated with the intervention. Participants are instructed to select on a scale from 1 ("No change or condition worsened") to 7 ("Much better, and with a considerable improvement that made all the difference") the statement that best reflected the impact of the intervention on their condition.
3 months follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Aveiro University

Collaboratori

Fundação para a Ciência e a Tecnologia
RISE Study Group

Investigatori

  • Direttore dello studio: Anabela Silva, PhD, School of Health Sciences, University of Aveiro

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 aprile 2023

Completamento primario (Effettivo)

15 aprile 2024

Completamento dello studio (Effettivo)

15 aprile 2024

Date di iscrizione allo studio

Primo inviato

23 febbraio 2023

Primo inviato che soddisfa i criteri di controllo qualità

8 marzo 2023

Primo Inserito (Effettivo)

21 marzo 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RCTCognitiveTraining

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data are not publicly available due to ethical and privacy restrictions of the approved study protocol. An anonymized analysis dataset may be made available to qualified researchers upon reasonable request to the principal investigator and subject to approval by the Ethics and Deontology Council of the University of Aveiro.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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