Chronic Low-back Pain
Conditions
Keywords
cognitive training, exercise, chronic low back pain, pain neuroscience education
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.
Interventions
OTHERExperimental
Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
OTHERExercise and PNE
Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
OTHERCognitive training
Online sessions of cognitive training.
Sponsors
Fundação para a Ciência e a Tecnologia
RISE Study Group
Aveiro University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale Numeric Pain Rating Scale | baseline | Measured with a 11-point scale ranging from 0 meaning no pain to 10 meaning the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Roland Morris disability questionnaire | 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. |
| Central sensitization Inventory | 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. |
| Hospital Anxiety and Depression Scale (HADS) | 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. |
| TAMPA Scale of Kinesiophobia | 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. |
| Cognitive Function | 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. |
| Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs) | 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. |
| Two-point discrimination | baseline | Two-point discrimination is used to assess cortical reorganization. |
| Patient's Global Impression of Change (PGIC) | 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. |
| Pain Catastrophizing Scale | 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. |
Countries
Portugal
Contacts
Primary ContactEllen P. Nery, Ms.
Backup ContactAnabela Silva
Outcome results
None listed