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

Not Applicable

Recruiting

• Conditions: Chronic Low-back Pain
• Interventions: Other: Exercise and PNE; Other: Experimental; Other: Cognitive training

• Registration Number: NCT05777343
• Lead Sponsor: Aveiro University

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.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-21
• Study Start: 2023-04-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09
• Primary Completion: 2024-02-10
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 2	Exercise and PNE	Participants will receive exercise and pain neuroscience education (PNE).
Intervention 1	Experimental	Participants will receive exercise, PNE and online cognitive training sessions.
Intervention 3	Cognitive training	Participants will receive online cognitive training sessions.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale Numeric Pain Rating Scale	3 months follow-up	Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".

Secondary Outcome Measures

Name	Time	Method
Central sensitization Inventory	3 months follow-up	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.
Pain Catastrophizing Scale	3 months follow-up.	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.
Two-point discrimination	3 months follow-up	Two-point discrimination is used to assess cortical reorganization.
Patient's Global Impression of Change (PGIC)	3 months follow-up.	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.
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)	3 months follow-up.	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.
Cognitive Function	3 months follow-up.	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.
Roland Morris disability questionnaire	3 months follow-up	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.
Hospital Anxiety and Depression Scale (HADS)	3 months follow-up.	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	3 months follow-up.	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.

Trial Locations

Locations (1)

University of Aveiro; 🇵🇹 Aveiro, Portugal