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

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental
Exercise and PNE
Cognitive training
Sponsored by
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring cognitive training, exercise, chronic low back pain, pain neuroscience education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Intervention 1

    Intervention 2

    Intervention 3

    Arm Description

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

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

    Participants will receive online cognitive training sessions.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Cognitive Function
    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.
    Cognitive Function
    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.
    Cognitive Function
    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.
    Roland Morris disability questionnaire
    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.
    Roland Morris disability questionnaire
    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.
    Roland Morris disability questionnaire
    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.
    Central sensitization Inventory
    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.
    Central sensitization Inventory
    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.
    Central sensitization Inventory
    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.
    Hospital Anxiety and Depression Scale (HADS)
    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.
    Hospital Anxiety and Depression Scale (HADS)
    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.
    Hospital Anxiety and Depression Scale (HADS)
    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.
    TAMPA Scale of Kinesiophobia
    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.
    TAMPA Scale of Kinesiophobia
    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.
    TAMPA Scale of Kinesiophobia
    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.
    Pain Catastrophizing Scale
    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.
    Pain Catastrophizing Scale
    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.
    Pain Catastrophizing Scale
    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.
    Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
    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.
    Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
    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.
    Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
    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.
    Two-point discrimination
    Two-point discrimination is used to assess cortical reorganization.
    Two-point discrimination
    Two-point discrimination is used to assess cortical reorganization.
    Two-point discrimination
    Two-point discrimination is used to assess cortical reorganization.
    Patient's Global Impression of Change (PGIC)
    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.
    Patient's Global Impression of Change (PGIC)
    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.

    Full Information

    First Posted
    February 23, 2023
    Last Updated
    March 8, 2023
    Sponsor
    Aveiro University
    Collaborators
    Fundação para a Ciência e a Tecnologia, RISE Study Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05777343
    Brief Title
    Exercise, PNE and Cognitive Training in Individuals With Chronic Low Back Pain
    Official Title
    Pain Neuroscience Education, Exercise, and Cognitive Training in Individuals With Idiopathic Chronic Low Back Pain: a Three-arm Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 10, 2023 (Anticipated)
    Primary Completion Date
    February 10, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aveiro University
    Collaborators
    Fundação para a Ciência e a Tecnologia, RISE Study Group

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low-back Pain
    Keywords
    cognitive training, exercise, chronic low back pain, pain neuroscience education

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    83 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention 1
    Arm Type
    Experimental
    Arm Description
    Participants will receive exercise, PNE and online cognitive training sessions.
    Arm Title
    Intervention 2
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive exercise and pain neuroscience education (PNE).
    Arm Title
    Intervention 3
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive online cognitive training sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Experimental
    Intervention Description
    Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
    Intervention Type
    Other
    Intervention Name(s)
    Exercise and PNE
    Intervention Description
    Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
    Intervention Type
    Other
    Intervention Name(s)
    Cognitive training
    Intervention Description
    Online sessions of cognitive training.
    Primary Outcome Measure Information:
    Title
    Numeric Pain Rating Scale Numeric Pain Rating Scale
    Description
    Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
    Time Frame
    baseline
    Title
    Numeric Pain Rating Scale Numeric Pain Rating Scale
    Description
    Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
    Time Frame
    post-intervention - 8 weeks
    Title
    Numeric Pain Rating Scale Numeric Pain Rating Scale
    Description
    Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
    Time Frame
    3 months follow-up
    Secondary Outcome Measure Information:
    Title
    Cognitive Function
    Description
    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.
    Time Frame
    baseline
    Title
    Cognitive Function
    Description
    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.
    Time Frame
    post-intervention - 8 weeks
    Title
    Cognitive Function
    Description
    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.
    Time Frame
    3 months follow-up.
    Title
    Roland Morris disability questionnaire
    Description
    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.
    Time Frame
    baseline
    Title
    Roland Morris disability questionnaire
    Description
    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.
    Time Frame
    post-intervention - 8 weeks
    Title
    Roland Morris disability questionnaire
    Description
    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.
    Time Frame
    3 months follow-up
    Title
    Central sensitization Inventory
    Description
    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.
    Time Frame
    baseline
    Title
    Central sensitization Inventory
    Description
    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.
    Time Frame
    post-intervention - 8 weeks
    Title
    Central sensitization Inventory
    Description
    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.
    Time Frame
    3 months follow-up
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Description
    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.
    Time Frame
    baseline
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Description
    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.
    Time Frame
    post-intervention - 8 weeks
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Description
    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.
    Time Frame
    3 months follow-up.
    Title
    TAMPA Scale of Kinesiophobia
    Description
    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.
    Time Frame
    baseline
    Title
    TAMPA Scale of Kinesiophobia
    Description
    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.
    Time Frame
    post-intervention - 8 weeks
    Title
    TAMPA Scale of Kinesiophobia
    Description
    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.
    Time Frame
    3 months follow-up.
    Title
    Pain Catastrophizing Scale
    Description
    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.
    Time Frame
    Baseline
    Title
    Pain Catastrophizing Scale
    Description
    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.
    Time Frame
    post-intervention - 8 weeks
    Title
    Pain Catastrophizing Scale
    Description
    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.
    Time Frame
    3 months follow-up.
    Title
    Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
    Description
    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.
    Time Frame
    baseline
    Title
    Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
    Description
    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.
    Time Frame
    post-intervention - 8 weeks
    Title
    Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
    Description
    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.
    Time Frame
    3 months follow-up.
    Title
    Two-point discrimination
    Description
    Two-point discrimination is used to assess cortical reorganization.
    Time Frame
    baseline
    Title
    Two-point discrimination
    Description
    Two-point discrimination is used to assess cortical reorganization.
    Time Frame
    post-intervention - 8 weeks
    Title
    Two-point discrimination
    Description
    Two-point discrimination is used to assess cortical reorganization.
    Time Frame
    3 months follow-up
    Title
    Patient's Global Impression of Change (PGIC)
    Description
    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.
    Time Frame
    post-intervention - 8 weeks
    Title
    Patient's Global Impression of Change (PGIC)
    Description
    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.
    Time Frame
    3 months follow-up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ellen P. Nery, Ms.
    Phone
    +351234370200
    Email
    ellen.nery@ua.pt
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anabela Silva
    Phone
    +351234370200
    Email
    asilva@ua.pt
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anabela Silva, PhD
    Organizational Affiliation
    School of Health Sciences, University of Aveiro
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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