Pain Neurophysiology Education in Chronic Low Back Pain

NCT ID: NCT06915532

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2024-04-30

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.

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)

Study Design

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

Study Groups

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

Group Type: ACTIVE_COMPARATOR

conventional rehabilitation

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Pain Neurophysiology Education

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Sponsors

Hopital Charles Nicolle

OTHER

Sponsor Role: lead

Responsible Party

Selma Bouden

assistant doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charles Nicolle Hospital

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

ECR-OMG-2024-324

Identifier Type: OTHER

Identifier Source: secondary_id

ECR-OMG-2024-325

Identifier Type: -

Identifier Source: org_study_id