Skip to main content
OpenTrials
Completed

NCT Number: NCT04191317

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Saúde

Aveiro, Portugal

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain Neuroscience Education and gradual exposure

Other

Education covering the pathophysiology of apin and exercises based on the gradual exposure principle

Pilates and postural education

Other

Postural education and pilates exercises

Primary outcomes

  1. Pain intensity

    Time frame: Baseline (week 0)

    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)

  2. Pain intensity

    Time frame: End of study - week 9

    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. Pain intensity

    Time frame: 3 months follow up

    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)

Secondary outcomes

  1. Disability

    Time frame: Baseline (week 0)

    Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24

  2. Disability

    Time frame: End of study - week 9

    Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24

  3. Disability

    Time frame: 3 months follow up

    Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24

  4. Knowledge of pain neurophysiology

    Time frame: Baseline - week 0

    Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19

  5. Knowledge of pain neurophysiology

    Time frame: End of study - week 9

    Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19

  6. Knowledge of pain neurophysiology

    Time frame: 3 months follow up

    Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19

  7. Pain catastrophizing

    Time frame: Baseline - week 0

    Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52

  8. Pain catastrophizing

    Time frame: End of study - week 9

    Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52

  9. Pain catastrophizing

    Time frame: 3 months follow up

    Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52

  10. Fear avoidance behavior

    Time frame: Baseline - week 0

    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

  11. Fear avoidance behavior

    Time frame: End of study - week 9

    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

  12. Fear avoidance behavior

    Time frame: 3 months follow up

    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

  13. Pain phenotype

    Time frame: Baseline - week 0

    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).

  14. Pain phenotype

    Time frame: End of study - week 9

    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).

  15. Pain phenotype

    Time frame: 3 months follow up

    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).

  16. Patient Global Impression of Change

    Time frame: Baseline - week 0

    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"

  17. Patient Global Impression of Change

    Time frame: End of study - week 9

    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"

  18. Patient Global Impression of Change

    Time frame: 3 months follow up

    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"

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2019
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.