Pain Neuroscience Education and Gradual Exposure to Exercise in Factory Workers With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Pain Neuroscience Education and Gradual Exposure to Exercise in Factory Workers With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04191317
• Other study ID #: 21-CED/2019
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2022
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the effectiveness of a pain neuroscience education (PNE) based programe and gradual exposure to exercise versus pilates on disability levels associated with chronic low back pain in factory workers. There will be two arms each one receiving one type of intervention over 8 weeks.

Description:

This will be a pilot randomized controlled and experimental study. There will be two groups, one group will receive an intervention strategy based in basic postural re-education exercises (Pilates) and self-management strategies, and the other group will perform a program based in pain neuroscience education and gradual exposure to exercise. Both interventions will be delivered in the physiotherapy office of a paper industry. Participants will be randomly allocated according to the work team they belong, to an intervention arm.

The inclusion criteria to participate in the study are: to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour and not receiving treatment for low back pain. Participants will be excluded if during the physical examination they show altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids; presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.

Once inclusion criteria have been ascertained, participants will be assessed for sociodemographic and anthropometric data, pain, disability, knowledge of pain neurophysiology, pain catastrophizing, fear of movement, presence of a neuropathic component, workstation evaluation and global impression of change related to intervention.

The intervention will last for 8 weeks, during which participants will have 1 face-to-face session per week with a duration of approximately 60 minutes each. One group (Pilates group) will receive an intervention based on Pilates' and and postural education. The other group will have theoretical sessions of PNE and gradual exposure to exercise (PNE plus graded exposure group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour;

• not receiving treatment for low back pain.

Exclusion Criteria:

• altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids;

• presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Pain Neuroscience Education and gradual exposure
Education covering the pathophysiology of apin and exercises based on the gradual exposure principle
• Pilates and postural education
Postural education and pilates exercises

Locations

Country	Name	City	State
Portugal	Escola Superior de Saúde	Aveiro

Sponsors (1)

Lead Sponsor	Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)	Baseline (week 0)
Primary	Pain intensity	Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)	End of study - week 9
Primary	Pain intensity	Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)	3 months follow up
Secondary	Disability	Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24	Baseline (week 0)
Secondary	Disability	Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24	End of study - week 9
Secondary	Disability	Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24	3 months follow up
Secondary	Knowledge of pain neurophysiology	Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19	Baseline - week 0
Secondary	Knowledge of pain neurophysiology	Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19	End of study - week 9
Secondary	Knowledge of pain neurophysiology	Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19	3 months follow up
Secondary	Pain catastrophizing	Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52	Baseline - week 0
Secondary	Pain catastrophizing	Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52	End of study - week 9
Secondary	Pain catastrophizing	Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52	3 months follow up
Secondary	Fear avoidance behavior	Measured using the Tampa Scale of Kinesiophobia, total score varies from 13 to 52, where 13 represents the less and 52 the greater level of fear of movement	Baseline - week 0
Secondary	Fear avoidance behavior	Measured using the Tampa Scale of Kinesiophobia, total score varies from 13 to 52, where 13 represents the less and 52 the greater level of fear of movement	End of study - week 9
Secondary	Fear avoidance behavior	Measured using the Tampa Scale of Kinesiophobia, total score varies from 13 to 52, where 13 represents the less and 52 the greater level of fear of movement	3 months follow up
Secondary	Pain phenotype	Measured using the Pain Detect Questionnaire. Total score varies from -1 to 38 points. Scores below 12 indicate little probability of a neuropathic component (85% chance of not having); scores between 12 - 19 reveal a mixed phenotype, whereas a score above 19 reveals high probability of neuropathic pain (90% chance).	Baseline - week 0
Secondary	Pain phenotype	Measured using the Pain Detect Questionnaire. Total score varies from -1 to 38 points. Scores below 12 indicate little probability of a neuropathic component (85% chance of not having); scores between 12 - 19 reveal a mixed phenotype, whereas a score above 19 reveals high probability of neuropathic pain (90% chance).	End of study - week 9
Secondary	Pain phenotype	Measured using the Pain Detect Questionnaire. Total score varies from -1 to 38 points. Scores below 12 indicate little probability of a neuropathic component (85% chance of not having); scores between 12 - 19 reveal a mixed phenotype, whereas a score above 19 reveals high probability of neuropathic pain (90% chance).	3 months follow up
Secondary	Patient Global Impression of Change	Measured using the Patient Global Impression of Change (PGIC) scale. This is a unidimensional measure widely used in chronic pain studies, in which the patients classify their improvements using a 7-point scale, varying from "1- no change" to "7 - a great deal better and a considerable improvement that has made all the difference"	Baseline - week 0
Secondary	Patient Global Impression of Change	Measured using the Patient Global Impression of Change (PGIC) scale. This is a unidimensional measure widely used in chronic pain studies, in which the patients classify their improvements using a 7-point scale, varying from "1- no change" to "7 - a great deal better and a considerable improvement that has made all the difference"	End of study - week 9
Secondary	Patient Global Impression of Change	Measured using the Patient Global Impression of Change (PGIC) scale. This is a unidimensional measure widely used in chronic pain studies, in which the patients classify their improvements using a 7-point scale, varying from "1- no change" to "7 - a great deal better and a considerable improvement that has made all the difference"	3 months follow up