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Cvičení, PNE a kognitivní trénink u jedinců s chronickou bolestí dolní části zad

18. září 2026 aktualizováno: Ellen Hirose Pereira Nery, Aveiro University

Vzdělávání, cvičení a kognitivní trénink u jedinců s idiopatickou chronickou bolestí dolní části zad o bolesti: Randomizovaná studie se třemi rameny

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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

99

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Portugalsko
    • Aveiro District
      • Aveiro, Aveiro District, Portugalsko
        • University of Aveiro

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 64 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention 1

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

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

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

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

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

Online sessions of cognitive training.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Numeric Pain Rating Scale Numeric Pain Rating Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cognitive Function
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: baseline

Two-point discrimination is used to assess cortical reorganization.
baseline
Two-point discrimination
Časové okno: post-intervention - 8 weeks

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

Two-point discrimination is used to assess cortical reorganization.
3 months follow-up
Patient's Global Impression of Change (PGIC)
Časové okno: 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)
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Aveiro University

Spolupracovníci

Fundação para a Ciência e a Tecnologia
RISE Study Group

Vyšetřovatelé

  • Ředitel studie: Anabela Silva, PhD, School of Health Sciences, University of Aveiro

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

10. dubna 2023

Primární dokončení (Aktuální)

15. dubna 2024

Dokončení studie (Aktuální)

15. dubna 2024

Termíny zápisu do studia

První předloženo

23. února 2023

První předloženo, které splnilo kritéria kontroly kvality

8. března 2023

První zveřejněno (Aktuální)

21. března 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RCTCognitiveTraining

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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