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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Experimental; Other: Exercise and PNE; Other: Cognitive training

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.

• Study Type: Interventional
• Enrollment (Estimated): 83
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen P. Nery, Ms.; Phone Number: +351234370200; Email: ellen.nery@ua.pt
• Study Contact Backup: Name: Anabela Silva; Phone Number: +351234370200; Email: asilva@ua.pt

Study Locations

• Portugal
  • Aveiro, Portugal
    • Recruiting
    • University of Aveiro
    • Contact: Ellen Nery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Aveiro University
• Collaborators: Fundação para a Ciência e a Tecnologia; RISE Study Group
• Investigators: Study Director: Anabela Silva, PhD, School of Health Sciences, University of Aveiro

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): February 10, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: exercise; chronic low back pain; cognitive training; pain neuroscience education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: RCTCognitiveTraining

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No