Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-06 @ 4:09 AM
Study NCT ID:
NCT07202533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Neuroscience Education and Exercise for Chronic Nonspecific Low Back Pain
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
Investigation of the Effectiveness of Exercise and Pain Neuroscience Education in Individuals With Chronic Nonspecific Low Back Pain With Central Sensitization
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
This study aims to evaluate the effects of adding Pain Neuroscience Education (PNE) to motor control exercises in individuals with chronic non-specific low back pain (CNSLBP) who also present with central sensitization. The study focuses on changes in pain intensity, pain-related factors, trunk muscle activation, gait, functionality, kinesiophobia, and quality of life.
Detailed Description:
This randomized controlled study aims to investigate the effects of combining PNE with motor control exercises in individuals with CNSLBP who demonstrate central sensitization (≥28 points on the Central Sensitization Inventory). Participants are randomly assigned into two groups: the intervention group (motor control exercises + PNE) and the control group (motor control exercises only). Both groups participate in motor control exercises twice a week for 8 weeks, under the supervision of a physiotherapist. The intervention group additionally receives six PNE sessions once per week for six weeks. PNE sessions are delivered by a certified physiotherapist using interactive presentations and question-answer discussions.
Assessments are performed pre- and post-intervention using the following tools:
* Central Sensitization Inventory (CSI) to determine the presence and severity of central sensitization.
* Numeric Pain Rating Scale (NPRS) for pain intensity.
* Revised Neurophysiology of Pain Questionnaire (rNPQ) for pain knowledge.
* Pain Catastrophizing Scale (PCS) for catastrophic thinking.
* Pressure Pain Threshold (PPT) using a digital algometer.
* Electromyographic (EMG) evaluation of trunk and lower extremity muscles using surface electrodes.
* Spatiotemporal gait analysis using OptoGait and Ultium Insole systems.
* Tampa Scale for Kinesiophobia (TSK) for fear of movement.
* Roland-Morris Disability Questionnaire (RMDQ) for disability level.
* Nottingham Health Profile (NHP) for quality of life.
Data will be analyzed using SPSS version 27. Normality of distribution will be tested with the Shapiro-Wilk test. Depending on the distribution, either parametric (paired t-test, independent t-test) or non-parametric tests (Wilcoxon signed-rank, Mann-Whitney U) will be applied. Pearson or Spearman correlation analyses will be used where appropriate.
Assessments are performed pre- and post-intervention using the following tools:
* Central Sensitization Inventory (CSI) to determine the presence and severity of central sensitization.
* Numeric Pain Rating Scale (NPRS) for pain intensity.
* Revised Neurophysiology of Pain Questionnaire (rNPQ) for pain knowledge.
* Pain Catastrophizing Scale (PCS) for catastrophic thinking.
* Pressure Pain Threshold (PPT) using a digital algometer.
* Electromyographic (EMG) evaluation of trunk and lower extremity muscles using surface electrodes.
* Spatiotemporal gait analysis using OptoGait and Ultium Insole systems.
* Tampa Scale for Kinesiophobia (TSK) for fear of movement.
* Roland-Morris Disability Questionnaire (RMDQ) for disability level.
* Nottingham Health Profile (NHP) for quality of life.
Data will be analyzed using SPSS version 27. Normality of distribution will be tested with the Shapiro-Wilk test. Depending on the distribution, either parametric (paired t-test, independent t-test) or non-parametric tests (Wilcoxon signed-rank, Mann-Whitney U) will be applied. Pearson or Spearman correlation analyses will be used where appropriate.
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?: