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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
99
Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
Online sessions of cognitive training.
University of Aveiro
Aveiro, Aveiro District, Portugal
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".
Time frame: baseline
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".
Time frame: post-intervention - 8 weeks
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".
Time frame: 3 months follow-up
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.
Time frame: baseline
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.
Time frame: post-intervention - 8 weeks
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.
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Time frame: 3 months follow-up.
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.
Time frame: baseline
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.
Time frame: post-intervention - 8 weeks
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.
Time frame: 3 months follow-up
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.
Time frame: baseline
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.
Time frame: post-intervention - 8 weeks
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.
Time frame: 3 months follow-up
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.
Time frame: baseline
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.
Time frame: post-intervention - 8 weeks
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.
Time frame: 3 months follow-up.
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.
Time frame: baseline
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.
Time frame: post-intervention - 8 weeks
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.
Time frame: 3 months follow-up.
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.
Time frame: Baseline
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.
Time frame: post-intervention - 8 weeks
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.
Time frame: 3 months follow-up.
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.
Time frame: baseline
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.
Time frame: post-intervention - 8 weeks
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.
Time frame: 3 months follow-up.
Two-point discrimination
Two-point discrimination is used to assess cortical reorganization.
Time frame: baseline
Two-point discrimination
Two-point discrimination is used to assess cortical reorganization.
Time frame: post-intervention - 8 weeks
Two-point discrimination
Two-point discrimination is used to assess cortical reorganization.
Time frame: 3 months follow-up
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.
Time frame: post-intervention - 8 weeks
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.
Time frame: 3 months follow-up.