Investigation of the Effectiveness of Exercise and Pain Neuroscience Education in Individuals With Chronic Nonspecific Low Back Pain With Central Sensitization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Hacettepe University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pain Intensity (Numerical Pain Rating Scale - NPRS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Volunteers who agree to participate in the study
- •Having a history of non-specific low back pain lasting at least 3 months
- •Having a pain intensity score of 3 or higher on the Numerical Pain Rating Scale (NPRS) within the last week
- •Scoring ≥28 on the Turkish version of the Central Sensitization Inventory.
Exclusion Criteria
- •Individuals with radicular symptoms or cauda equina syndrome
- •Severe osteoporosis
- •Spondyloarthropathy
- •Spondylolisthesis
- •Lumbar spinal stenosis
- •Lumbar fractures
- •Malignant tumors
- •Severe comorbidities (neurological, neuromuscular, cardiac, or psychiatric disorders)
- •Individuals who have undergone spinal surgery
- •Individuals who are familiar with motor control exercises or who have previously received pain neuroscience education
Arms & Interventions
Motor Control Exercises + Pain Neuroscience Education
This group will receive the same motor control exercise program as the control group, plus a 6-week PNE program delivered once per week. The PNE program consists of 6 weekly sessions, delivered via slide presentations and interactive discussions, covering topics such as nociception, central sensitization, neuroplasticity, and pain coping strategies. Sessions are delivered by a certified physiotherapist.
Intervention: Motor Control Exercises (Other)
Motor Control Exercises
This group will receive motor control exercises only.
Intervention: Motor Control Exercises (Other)
Motor Control Exercises + Pain Neuroscience Education
This group will receive the same motor control exercise program as the control group, plus a 6-week PNE program delivered once per week. The PNE program consists of 6 weekly sessions, delivered via slide presentations and interactive discussions, covering topics such as nociception, central sensitization, neuroplasticity, and pain coping strategies. Sessions are delivered by a certified physiotherapist.
Intervention: Pain Neuroscience Education (Other)
Outcomes
Primary Outcomes
Pain Intensity (Numerical Pain Rating Scale - NPRS)
Time Frame: Baseline and post-intervention (8 weeks)
Change in pain intensity will be assessed using a 0-10 Numerical Pain Rating Scale at baseline and post-intervention. Higher scores indicate greater pain severity.
Central Sensitization (Central Sensitization Inventory - CSI)
Time Frame: Baseline and post-intervention (8 weeks)
The CSI-A section will be used to evaluate symptoms related to central sensitization. Total scores range from 0-100, with higher scores indicating greater sensitization.
Pain Knowledge (Revised Neurophysiology of Pain Questionnaire - rNPQ)
Time Frame: Baseline and post-intervention (8 weeks)
Participants' knowledge about pain neurophysiology will be assessed. The number of correct responses will be calculated.
Disability (Roland-Morris Disability Questionnaire - RMDQ)
Time Frame: Baseline and post-intervention (8 weeks)
Functional disability due to low back pain will be assessed using the RMDQ, a 24-item self-report questionnaire.
Muscle Activation (Surface EMG Analysis)
Time Frame: Baseline and post-intervention (8 weeks)
Surface EMG will evaluate activation levels of bilateral external oblique, internal oblique, transversus abdominis, and tibialis anterior muscles during gait.
Pressure Paın Threshold Measurement
Time Frame: Baseline and post-intervention (8 weeks)
PPT will be measured using a digital algometer on the lumbar region. Higher values indicate reduced pain sensitivity.
Secondary Outcomes
- Kinesiophobia (Tampa Scale for Kinesiophobia - TSK)(Baseline and post-intervention (8 weeks))
- Pain Catastrophizing (Pain Catastrophizing Scale - PCS)(Baseline and post-intervention (8 weeks))
- Gait Analysis (OptoGait Photocell System)(Baseline and post-intervention (8 weeks))
- Gait Analysis (Noraxon Ultium Insole)(Baseline and post-intervention (8 weeks))
- Quality of Life (Nottingham Health Profile - NHP)(Baseline and post-intervention (8 weeks))
Investigators
Ayşe ŞİMŞEK
→ PhD Candidate, Research Assistant
Hacettepe University