Chronic Low Back Pain (CLBP)PNE-LBPNCT06915532
Pain Neurophysiology Education in Chronic Low Back Pain
A study testing Pain Neurophysiology Education and conventional rehabilitation in people with Chronic Low Back Pain (CLBP), run by Hopital Charles Nicolle at 1 site in Tunisia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Pain Neurophysiology Education and conventional rehabilitation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 or older
- patients suffering from chronic common low back pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Pain Neurophysiology Education, conventional rehabilitation
- Keywords
- chronic low back pain, Pain Neurophysiology Education, Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neurophysiology EducationBehavioural
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.
conventional rehabilitationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Pain Neurophysiology Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 of the lumbar spine was evaluated in flexion with the Schober index, and also in extension and inclination
Measured: 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 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
Measured: 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 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
Measured: 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 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
Measured: Kinesiophobia was evaluated at baseline prior to the intervention (T0) and at the end of the 4-week treatment period (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start2 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Charles Nicolle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Bouden, Hopital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915532
- Sponsor's protocol ID
- ECR-OMG-2024-325
- Other IDs
- ECR-OMG-2024-324
- Acronym
- PNE-LBP
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Neurophysiology Education in Chronic Low Back Pain: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06915532
- Acronym / sponsor ID
- PNE-LBP / ECR-OMG-2024-325
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- chronic low back pain, Pain Neurophysiology Education, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hopital Charles NicolleUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: conventional rehabilitationConventional 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 |
| PNE group | Experimental | Behavioral: Pain Neurophysiology EducationEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18 or older
- patients suffering from chronic common low back pain
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neurophysiology EducationThe 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. | Behavioural | PNE group |
| conventional rehabilitationConventional 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 | Procedure or surgery | control group |
Primary outcome
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)
4 secondary outcomes
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).
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).
Catastrophizing
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neurophysiology Education and conventional rehabilitation in people with Chronic Low Back Pain (CLBP), run by Hopital Charles Nicolle at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.