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

NCT04191317 | Completed

• 1 other identifier: 21-CED/2019
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• Disability

  Baseline (week 0)

• Disability

  End of study - week 9

• Disability

  3 months follow up

• Knowledge of pain neurophysiology

  Baseline - week 0

• Knowledge of pain neurophysiology

  End of study - week 9

Study Arms (2)

Pain Neuroscience Education and gradual exposure

EXPERIMENTAL

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

Pilates and postural education

ACTIVE COMPARATOR

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

Interventions

Pain Neuroscience Education and gradual exposure OTHER

Education covering the pathophysiology of apin and exercises based on the gradual exposure principle

Pain Neuroscience Education and gradual exposure

Pilates and postural education OTHER

Postural education and pilates exercises

Pilates and postural education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead

Study Sites (1)

Escola Superior de Saúde

Aveiro, Portugal

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Two arms, each receiving a different intervention.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: December 2, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)