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Clinical Trials/NCT04191317
NCT04191317
Completed
Not Applicable

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

Aveiro University1 site in 1 country37 target enrollmentDecember 2, 2019
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Aveiro University
Enrollment
37
Locations
1
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 2, 2019
End Date
July 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aveiro University
Responsible Party
Principal Investigator
Principal Investigator

Anabela G Silva

Doctor

Aveiro University

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.

Outcomes

Primary Outcomes

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

  • Disability(3 months follow up)
  • Pain phenotype(3 months follow up)
  • Pain catastrophizing(3 months follow up)
  • Fear avoidance behavior(3 months follow up)
  • Knowledge of pain neurophysiology(3 months follow up)
  • Patient Global Impression of Change(3 months follow up)

Study Sites (1)

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