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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Education covering the pathophysiology of apin and exercises based on the gradual exposure principle
Postural education and pilates exercises
Escola Superior de Saúde
Aveiro, Portugal
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)
Time frame: 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)
Time frame: 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)
Time frame: 3 months follow up
Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Time frame: Baseline (week 0)
Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Time frame: End of study - week 9
Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Time frame: 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
Time frame: Baseline - week 0
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Knowledge of pain neurophysiology
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Time frame: 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
Time frame: 3 months follow up
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Time frame: Baseline - week 0
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Time frame: End of study - week 9
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 3 months follow up