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Ćwiczenia, PNE i trening poznawczy u osób z przewlekłym bólem krzyża

18 września 2026 zaktualizowane przez: Ellen Hirose Pereira Nery, Aveiro University

Ból Neuroscience Edukacja, ćwiczenia i trening poznawczy u osób z idiopatycznym przewlekłym bólem krzyża: trójramienna randomizowana próba

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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

99

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Portugalia
    • Aveiro District
      • Aveiro, Aveiro District, Portugalia
        • University of Aveiro

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 64 lata (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Intervention 1

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

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

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

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

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

Online sessions of cognitive training.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Numeric Pain Rating Scale Numeric Pain Rating Scale
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cognitive Function
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: baseline

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

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

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Aveiro University

Współpracownicy

Fundação para a Ciência e a Tecnologia
RISE Study Group

Śledczy

  • Dyrektor Studium: Anabela Silva, PhD, School of Health Sciences, University of Aveiro

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 kwietnia 2023

Zakończenie podstawowe (Rzeczywisty)

15 kwietnia 2024

Ukończenie studiów (Rzeczywisty)

15 kwietnia 2024

Daty rejestracji na studia

Pierwszy przesłany

23 lutego 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 marca 2023

Pierwszy wysłany (Rzeczywisty)

21 marca 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RCTCognitiveTraining

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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