Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT07202533

Pain Neuroscience Education and Exercise for Chronic Nonspecific Low Back Pain

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
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMotor Control ExercisesParticipants will perform these exercises under physiotherapist supervision twice per week for 8 weeks. Exercises focus on improving deep trunk muscle coordination and stability.
OTHERPain Neuroscience EducationA 6-week educational program with weekly sessions using slide presentations and interactive discussions, covering pain neurophysiology, central sensitization, and pain coping strategies, delivered by a certified physiotherapist.
OTHERMotor Control ExercisesParticipants will perform these exercises under physiotherapist supervision twice per week for 8 weeks. Exercises focus on improving deep trunk muscle coordination and stability.

Timeline

Start date
2024-08-29
Primary completion
2025-08-08
Completion
2026-03-31
First posted
2025-10-01
Last updated
2026-02-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07202533. Inclusion in this directory is not an endorsement.