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Bewegung, PNE und kognitives Training bei Personen mit chronischen Rückenschmerzen

18. September 2026 aktualisiert von: Ellen Hirose Pereira Nery, Aveiro University

Schmerzneurowissenschaftliche Aufklärung, Bewegung und kognitives Training bei Personen mit idiopathischen chronischen Rückenschmerzen: eine dreiarmige randomisierte Studie

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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

99

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Portugal
    • Aveiro District
      • Aveiro, Aveiro District, Portugal
        • University of Aveiro

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 64 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention 1

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

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

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

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

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

Online sessions of cognitive training.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Numeric Pain Rating Scale Numeric Pain Rating Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cognitive Function
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: baseline

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

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

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aveiro University

Mitarbeiter

Fundação para a Ciência e a Tecnologia
RISE Study Group

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. April 2023

Primärer Abschluss (Tatsächlich)

15. April 2024

Studienabschluss (Tatsächlich)

15. April 2024

Studienanmeldedaten

Zuerst eingereicht

23. Februar 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. März 2023

Zuerst gepostet (Tatsächlich)

21. März 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RCTCognitiveTraining

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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