Clinical trial NCT04191317: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Aveiro University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms, each receiving a different intervention.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline (week 0)
measure: Pain intensity
timeFrame: End of study - week 9
measure: Pain intensity
timeFrame: 3 months follow up
Secondary outcomes:
measure: Disability
timeFrame: Baseline (week 0)
measure: Disability
timeFrame: End of study - week 9
measure: Disability
timeFrame: 3 months follow up
measure: Knowledge of pain neurophysiology
timeFrame: Baseline - week 0
measure: Knowledge of pain neurophysiology
timeFrame: End of study - week 9
measure: Knowledge of pain neurophysiology
timeFrame: 3 months follow up
measure: Pain catastrophizing
timeFrame: Baseline - week 0
measure: Pain catastrophizing
timeFrame: End of study - week 9
measure: Pain catastrophizing
timeFrame: 3 months follow up
measure: Fear avoidance behavior
timeFrame: Baseline - week 0
measure: Fear avoidance behavior
timeFrame: End of study - week 9
measure: Fear avoidance behavior
timeFrame: 3 months follow up
measure: Pain phenotype
timeFrame: Baseline - week 0
measure: Pain phenotype
timeFrame: End of study - week 9
measure: Pain phenotype
timeFrame: 3 months follow up
measure: Patient Global Impression of Change
timeFrame: Baseline - week 0
measure: Patient Global Impression of Change
timeFrame: End of study - week 9
measure: Patient Global Impression of Change
timeFrame: 3 months follow up
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: Escola Superior de Saúde
Study officials:
References: