Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 6:54 AM
Study NCT ID:
NCT06915532
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2025-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Neurophysiology Education in Chronic Low Back Pain
Sponsor:
Hopital Charles Nicolle
Organization:
Study Overview
Official Title:
Effectiveness of Pain Neurophysiology Education in Chronic Low Back Pain: a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNE-LBP
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ECR-OMG-2024-324 | OTHER | Charles Nicolle Hospital | View |