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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Pain Neuroscience Education and gradual exposure
* Other: Pilates and postural education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms, each receiving a different intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Neuroscience Education and gradual exposure<br>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. | Other: Pain Neuroscience Education and gradual exposure<br>* Education covering the pathophysiology of apin and exercises based on the gradual exposure principle<br>|
| Active Comparator: Pilates and postural education<br>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. | Other: Pilates and postural education<br>* Postural education and pilates exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24 | Baseline (week 0) | 
| Disability | Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24 | End of study - week 9 | 
| Disability | Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24 | 3 months follow up | 
| Knowledge of pain neurophysiology | Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19 | Baseline - week 0 | 
| 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 | 
| 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 | 
| Pain catastrophizing | Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52 | Baseline - week 0 | 
| Pain catastrophizing | Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52 | End of study - week 9 | 
| Pain catastrophizing | Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52 | 3 months follow up | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |