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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777343
• Other study ID #: RCTCognitiveTraining
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2023
• Source: Aveiro University
• Contact: Ellen P. Nery, Ms.
• Phone: +351234370200
• Email: ellen.nery[@]ua.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83
• Est. completion date: March 1, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Experimental
Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
• Exercise and PNE
Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
• Cognitive training
Online sessions of cognitive training.

Locations

Country	Name	City	State
Portugal	University of Aveiro	Aveiro

Sponsors (3)

Lead Sponsor	Collaborator
Aveiro University	Fundação para a Ciência e a Tecnologia, RISE Study Group

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	Two-point discrimination	Two-point discrimination is used to assess cortical reorganization.	baseline
Secondary	Two-point discrimination	Two-point discrimination is used to assess cortical reorganization.	post-intervention - 8 weeks
Secondary	Two-point discrimination	Two-point discrimination is used to assess cortical reorganization.	3 months follow-up
Secondary	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
Secondary	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.