Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT07202533
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.
Study:
NCT07202533
Study Brief:
Protocol Section:
NCT07202533