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

NCT ID: NCT04191317

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2021-07-30

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).

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pain Neuroscience Education and gradual exposure

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.

Group Type: EXPERIMENTAL

Pain Neuroscience Education and gradual exposure

Intervention Type: OTHER

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

Pilates and postural education

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.

Group Type: ACTIVE_COMPARATOR

Pilates and postural education

Intervention Type: OTHER

Postural education and pilates exercises

Interventions

Pain Neuroscience Education and gradual exposure

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

Intervention Type: OTHER

Pilates and postural education

Postural education and pilates exercises

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aveiro University

OTHER

Sponsor Role: lead

Responsible Party

Anabela G Silva

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Escola Superior de Saúde

Aveiro, , Portugal

Countries

Portugal

Other Identifiers

21-CED/2019

Identifier Type: -

Identifier Source: org_study_id