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| Name | Class |
|---|---|
| Fundação para a Ciência e a Tecnologia | OTHER |
| RISE Study Group | NETWORK |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1 | Experimental | Participants will receive exercise, PNE and online cognitive training sessions. |
|
| Intervention 2 | Active Comparator | Participants will receive exercise and pain neuroscience education (PNE). |
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| Intervention 3 | Active Comparator | Participants will receive online cognitive training sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Other | Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen P. Nery, Ms. | Contact | +351234370200 | ellen.nery@ua.pt | |
| Anabela Silva | Contact | +351234370200 | asilva@ua.pt |
| Name | Affiliation | Role |
|---|---|---|
| Anabela Silva, PhD | School of Health Sciences, University of Aveiro | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Aveiro | Recruiting | Aveiro | Portugal |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise and PNE | Other | Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education). |
|
| Cognitive training | Other | Online sessions of cognitive training. |
|
| 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. |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |