Pain Neurophysiology Education in Chronic Low Back Pain (PNE-LBP)

April 4, 2025 updated by: Selma Bouden, Hopital Charles Nicolle

Effectiveness of Pain Neurophysiology Education in Chronic Low Back Pain: a Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of our study was to compare the effectiveness of PNE in combination with conventional rehabilitation to the effectiveness of conventional rehabilitation alone in the management of patients with chronic low back pain, in terms of pain perception, functional capacity, and psychological well-being.

The inverstigators conducted a randomized controlled study, over a period of 3 months (from January 2024 to March 2024), in the rehabilitation and rheumatology department of Charles Nicolle Hospital in Tunis. Participants were informed about the nature of the study, and written informed consent was obtained from all participants prior to participation.

The study included patients aged 18 or older, suffering from chronic common low back pain.

The patients were randomized into 2 groups: control group who received conventional rehabilitation only and PNE group who received PNE combined with conventional rehabilitation.

Each patient, whether in control group or PNE group, underwent a total of 12 sessions, over a 4-week period, with a frequency of 3 sessions per week. Each session lasted 60 minutes.

• Conventional Rehabilitation Protocol

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 vertebral issues.

    • PNE protocol 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.

Each session in Group B began with 30 minutes of PNE and the last 30 minutes were devoted to conventional rehabilitation.

Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).

Baseline assessment concerned sociodemographic characteristics (age, gender, body mass index (BMI), marital status, occupation, physical activity) and disease characteristics (treatment modalities, duration of symptoms).

Outcome measurements at T0 and T1 included:

  • Pain intensity: measured using the Visual Analog Scale (VAS).
  • Mobility of the lumbar spine: evaluated in flexion with the Fingertip-to-floor test (FFT) and the Schober index, and also in extension and inclination.
  • Functional impairment: was assessed using the "Oswestry Disability Questionnaire".
  • Catastrophizing: was evaluated using the Pain Catastrophizing Scale (PCS).
  • Kinesiophobia was evaluated using the Tampa Scale of Kinesiophobia (TSK).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • Charles Nicolle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group

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

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
Experimental: PNE group

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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: pain intensity was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mobility of the lumbar spine
Time Frame: Mobility was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Mobility of the lumbar spine was evaluated in flexion with the Schober index, and also in extension and inclination
Mobility was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Functional impairment
Time Frame: Functional impairment was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Functional impairment was assessed using the "Oswestry Disability Questionnaire" (ODI) which measures the degree of disability and estimates the quality of life in patients with chronic low back pain. The questionnaire consists of 10 questions, with each question offering 6 answer options, scored from 0 to 6. A score of 0 corresponds to normal function, while a score of 6 indicates severely diminished function
Functional impairment was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Catastrophizing
Time Frame: Catastrophizing was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Catastrophizing was evaluated using the Pain Catastrophizing Scale (PCS). The PCS evaluates catastrophic thoughts related to pain and consists of 13 statements describing different thoughts and feelings that may be experienced during pain. Participants rate these statements on a 5-point Likert scale (0 = not at all; 4 = all the time). The sum of these scores results in a total score ranging from 0 to 52. Higher scores indicate higher pain catastrophizing
Catastrophizing was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Kinesiophobia
Time Frame: Kinesiophobia was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Kinesiophobia was evaluated using the Tampa Scale of Kinesiophobia (TSK). TSK contains 17 statements regarding fear of movement or re-injury, each rated on a 4-point Likert scale (1 = strongly disagree; 4 = strongly agree). Total scores range from 17 to 68, with higher scores indicating greater fear-avoidance behaviors
Kinesiophobia was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Charles Nicolle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECR-OMG-2024-325
  • ECR-OMG-2024-324 (Other Identifier: Charles Nicolle Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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