Pain Neurophysiology Education in Chronic Low Back Pain

NCT06915532 | Completed

• 2 other identifiers: ECR-OMG-2024-325ECR-OMG-2024-324
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators conducted a randomized controlled study including 22 patients suffering from chronic common low back pain. Patients were randomized into 2 groups: Control group received conventional rehabilitation only (11 patients) and PNE group received PNE combined with conventional rehabilitation (11patients). Outcome measures were pain, mobility of the lumbar spine, functional impairment, catastrophizing and kinesiophobia.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

chronic low back pain; Pain Neurophysiology Education; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity was measured using the Visual Analog Scale (VAS) (0-10; with 0 representing no pain and 10 representing the worst pain)

  pain intensity was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).

Secondary Outcomes (4)

• Mobility of the lumbar spine

  Mobility was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).

• Functional impairment

  Functional impairment was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).

• Catastrophizing

  Catastrophizing was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).

• Kinesiophobia

  Kinesiophobia was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).

Study Arms (2)

control group

ACTIVE COMPARATOR

Conventional reeducation focused the first week on analgesic approach including: * Education and lifestyle * Massage and electrotherapy * Pelvic and lumbar movement awareness * Breathing exercises Then in week 2 and beyond, physiotherapist continued analgesic work and physical training: * Joint mobility and muscle flexibility * Muscle strengthening * Proprioceptive rehabilitation

Procedure: conventional rehabilitation

PNE group

EXPERIMENTAL

Each session in PNE group began with 30 minutes of PNE and the last 30 minutes were devoted to conventional rehabilitation. The program used for PNE was based on a brochure written in the Tunisian dialect with simple, patient-accessible language. The brochure includes different sections: definition of pain, origin of pain, types of pain, components of pain, role of nervous system in pain modulation and pain management. Thus, all main concepts of the neurophysiology of pain were explained and discussed using visual presentation. At the end of the sessions, a test was provided to the patient to assess their understanding of the brochure's content. At the follow-up session a month later, the main ideas taught were reinforced and any questions were answered.

Behavioral: Pain Neurophysiology Education

Interventions

Pain Neurophysiology Education BEHAVIORAL

The program used for PNE was based on a brochure written in the Tunisian dialect with simple, patient-accessible language. The brochure includes different sections: definition of pain, origin of pain, types of pain, components of pain, role of nervous system in pain modulation and pain management. Thus, all main concepts of the neurophysiology of pain were explained and discussed using visual presentation. At the end of the sessions, a test was provided to the patient to assess their understanding of the brochure's content. At the follow-up session a month later, the main ideas taught were reinforced and any questions were answered.

PNE group

conventional rehabilitation PROCEDURE

Conventional reeducation focused the first week on analgesic approach including: * Education and lifestyle: Emphasizing weight management, autonomy in chronic low back pain management, and encouragement of physical activity. * Massage and electrotherapy: To alleviate pain, enhance circulation, and relax muscles. * Pelvic and lumbar movement awareness: Exercises focused on improving the control of pelvic movements. * Breathing exercises: Breathing techniques to reduce tension and improve awareness. Then in week 2 and beyond, physiotherapist continued analgesic work and physical training: * Joint mobility and muscle flexibility: Exercises target mobility improvement, muscle strengthening, and stretching, with emphasis on posture control and lumbar mobility. * Muscle strengthening: Focused on abdominal and spinal muscles, promoting spinal stability and improving trunk control. * Proprioceptive rehabilitation: Enhancing lumbar-pelvic vigilance to stabilize the spine and prevent further ve

control group

Eligibility Criteria

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

You may qualify if:

• patients aged 18 or older
• patients suffering from chronic common low back pain

You may not qualify if:

• acute and sub-acute low back pain
• specific causes of low back pain with an identifiable cause (infectious, inflammatory, tumoral, etc.)
• neurological complications associated with low back pain, such as cauda equina syndrome or muscle weakness.
• history of lumbar surgery within the past 6 months
• recent vertebral fractures

Sponsors & Collaborators

• Hopital Charles Nicolle: lead

Study Sites (1)

Charles Nicolle Hospital

Tunis, Tunisia

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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: assistant doctor

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 8, 2025
• Study Start: January 2, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)