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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pain Neuroscience Education and gradual exposure
Pilates and postural education
Sponsored by
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Escola Superior de Saúde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain Neuroscience Education and gradual exposure

Pilates and postural education

Arm Description

Education explaining the neurophysiological processes that lead to chronic pain, in order to change maladaptive belief towards disease, reconceptualising them and desensitizing the Central Nervous system. On first session of gradual exposure the patients are challenged to create a hierarchically list with the functional activities they experience fear, and exposure begins with the one they have less. Both the therapist and participant will determine a specific group of exercises after the patient understands the benign nature of pain, and will be evaluated the maximal performance of the individual to perform each exercise separately.

In the first session, basic Pilates principles will be taught and reinforced at the beginning of the follow up sessions, including: postural alignment (neutral spine position, shoulder blade and neck position) and core recruitment along with a controlled breathing. Each session will have a warm up, mobility, stability and strengthening exercises and a cool down period.

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Knowledge of pain neurophysiology
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Knowledge of pain neurophysiology
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Knowledge of pain neurophysiology
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
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
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
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
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).
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).
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).
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"
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"
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"

Full Information

First Posted
December 5, 2019
Last Updated
July 14, 2022
Sponsor
Aveiro University
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1. Study Identification

Unique Protocol Identification Number
NCT04191317
Brief Title
Pain Neuroscience Education and Gradual Exposure to Exercise in Factory Workers With Chronic Low Back Pain
Official Title
Pain Neuroscience Education and Gradual Exposure to Exercise in Factory Workers With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms, each receiving a different intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Neuroscience Education and gradual exposure
Arm Type
Experimental
Arm Description
Education explaining the neurophysiological processes that lead to chronic pain, in order to change maladaptive belief towards disease, reconceptualising them and desensitizing the Central Nervous system. On first session of gradual exposure the patients are challenged to create a hierarchically list with the functional activities they experience fear, and exposure begins with the one they have less. Both the therapist and participant will determine a specific group of exercises after the patient understands the benign nature of pain, and will be evaluated the maximal performance of the individual to perform each exercise separately.
Arm Title
Pilates and postural education
Arm Type
Active Comparator
Arm Description
In the first session, basic Pilates principles will be taught and reinforced at the beginning of the follow up sessions, including: postural alignment (neutral spine position, shoulder blade and neck position) and core recruitment along with a controlled breathing. Each session will have a warm up, mobility, stability and strengthening exercises and a cool down period.
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education and gradual exposure
Intervention Description
Education covering the pathophysiology of apin and exercises based on the gradual exposure principle
Intervention Type
Other
Intervention Name(s)
Pilates and postural education
Intervention Description
Postural education and pilates exercises
Primary Outcome Measure Information:
Title
Pain intensity
Description
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)
Time Frame
Baseline (week 0)
Title
Pain intensity
Description
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)
Time Frame
End of study - week 9
Title
Pain intensity
Description
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)
Time Frame
3 months follow up
Secondary Outcome Measure Information:
Title
Disability
Description
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Time Frame
Baseline (week 0)
Title
Disability
Description
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Time Frame
End of study - week 9
Title
Disability
Description
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Time Frame
3 months follow up
Title
Knowledge of pain neurophysiology
Description
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Time Frame
Baseline - week 0
Title
Knowledge of pain neurophysiology
Description
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Time Frame
End of study - week 9
Title
Knowledge of pain neurophysiology
Description
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Time Frame
3 months follow up
Title
Pain catastrophizing
Description
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Time Frame
Baseline - week 0
Title
Pain catastrophizing
Description
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Time Frame
End of study - week 9
Title
Pain catastrophizing
Description
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Time Frame
3 months follow up
Title
Fear avoidance behavior
Description
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
Time Frame
Baseline - week 0
Title
Fear avoidance behavior
Description
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
Time Frame
End of study - week 9
Title
Fear avoidance behavior
Description
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
Time Frame
3 months follow up
Title
Pain phenotype
Description
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).
Time Frame
Baseline - week 0
Title
Pain phenotype
Description
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).
Time Frame
End of study - week 9
Title
Pain phenotype
Description
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).
Time Frame
3 months follow up
Title
Patient Global Impression of Change
Description
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"
Time Frame
Baseline - week 0
Title
Patient Global Impression of Change
Description
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"
Time Frame
End of study - week 9
Title
Patient Global Impression of Change
Description
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"
Time Frame
3 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Escola Superior de Saúde
City
Aveiro
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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