Skip to main content
OpenTrials
Completed

NCT Number: NCT05777343

Exercise, PNE and Cognitive Training in Individuals With Chronic Low Back Pain

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low-back Pain Behavior Motor Activity

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Aveiro

Aveiro, Aveiro District, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Experimental

Other

Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).

Exercise and PNE

Other

Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).

Cognitive Training

Other

Online sessions of cognitive training.

Primary outcomes

  1. Numeric Pain Rating Scale Numeric Pain Rating Scale

    Time frame: baseline

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

  2. Numeric Pain Rating Scale Numeric Pain Rating Scale

    Time frame: post-intervention - 8 weeks

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

  3. Numeric Pain Rating Scale Numeric Pain Rating Scale

    Time frame: 3 months follow-up

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

Secondary outcomes

  1. Cognitive Function

    Time frame: 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.

  2. Cognitive Function

    Time frame: 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.

  3. Cognitive Function

    Time frame: 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.

  4. Roland Morris disability questionnaire

    Time frame: 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.

  5. Roland Morris disability questionnaire

    Time frame: 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.

  6. Roland Morris disability questionnaire

    Time frame: 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.

  7. Central sensitization Inventory

    Time frame: 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.

  8. Central sensitization Inventory

    Time frame: 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.

  9. Central sensitization Inventory

    Time frame: 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.

  10. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  11. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  12. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

  13. TAMPA Scale of Kinesiophobia

    Time frame: 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.

  14. TAMPA Scale of Kinesiophobia

    Time frame: 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.

  15. TAMPA Scale of Kinesiophobia

    Time frame: 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.

  16. Pain Catastrophizing Scale

    Time frame: 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.

  17. Pain Catastrophizing Scale

    Time frame: 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.

  18. Pain Catastrophizing Scale

    Time frame: 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.

  19. Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)

    Time frame: 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.

  20. Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)

    Time frame: 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.

  21. Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)

    Time frame: 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.

  22. Two-point discrimination

    Time frame: baseline

    Two-point discrimination is used to assess cortical reorganization.

  23. Two-point discrimination

    Time frame: post-intervention - 8 weeks

    Two-point discrimination is used to assess cortical reorganization.

  24. Two-point discrimination

    Time frame: 3 months follow-up

    Two-point discrimination is used to assess cortical reorganization.

  25. Patient's Global Impression of Change (PGIC)

    Time frame: 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.

  26. Patient's Global Impression of Change (PGIC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia
  • RISE Study Group

Registry information

Official study title

Pain Neuroscience Education, Exercise, and Cognitive Training in Individuals With Idiopathic Chronic Low Back Pain: a Three-arm Randomized Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2023
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.