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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Other: Experimental
* Other: Exercise and PNE
* Other: Cognitive training


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 1<br>Participants will receive exercise, PNE and online cognitive training sessions. | Other: Experimental<br>* Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).<br>|
| Active Comparator: Intervention 2<br>Participants will receive exercise and pain neuroscience education (PNE). | Other: Exercise and PNE<br>* Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).<br>|
| Active Comparator: Intervention 3<br>Participants will receive online cognitive training sessions. | Other: Cognitive training<br>* Online sessions of cognitive training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 months follow-up. | 
| Two-point discrimination | Two-point discrimination is used to assess cortical reorganization. | baseline | 
| Two-point discrimination | Two-point discrimination is used to assess cortical reorganization. | post-intervention - 8 weeks | 
| Two-point discrimination | Two-point discrimination is used to assess cortical reorganization. | 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. | 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. | 3 months follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive training, exercise, chronic low back pain, pain neuroscience education