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NCT Number: NCT07202533

Pain Neuroscience Education and Exercise for Chronic Nonspecific Low Back Pain

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Non-Specific Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Karabük Province, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motor control exercises

Other

Participants will perform these exercises under physiotherapist supervision twice per week for 8 weeks. Exercises focus on improving deep trunk muscle coordination and stability.

Pain neuroscience education

Other

A 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Kinesiophobia (Tampa Scale for Kinesiophobia - TSK)

    Time frame: Baseline and post-intervention (8 weeks)

    Fear of movement will be evaluated with the TSK. Total scores range from 17-68. Higher scores represent more fear-avoidance behavior.

  2. Pain Catastrophizing (Pain Catastrophizing Scale - PCS)

    Time frame: Baseline and post-intervention (8 weeks)

    Total PCS scores will be used to assess exaggerated negative thoughts related to pain. Higher scores indicate greater catastrophizing.

  3. Gait Analysis (OptoGait Photocell System)

    Time frame: Baseline and post-intervention (8 weeks)

    Spatiotemporal characteristics of gait will be assessed using a validated and reliable treadmill-based OptoGait photocell system (Version 1.6.4.0, Microgate, Bolzano, Italy). All participants will be asked to walk on the treadmill and select a speed at which they feel most comfortable. After the participant has become accustomed to walking on the treadmill and determined their preferred speed, spatiotemporal parameters will be recorded during a one-minute walking trial.

  4. Gait Analysis (Noraxon Ultium Insole)

    Time frame: Baseline and post-intervention (8 weeks)

    Spatiotemporal gait parameters will be assessed using the Ultium Insole SmartLead pedobarographic analysis system (SmartLead, Noraxon, Scottsdale, AZ, USA). Participants will walk at a self-selected comfortable speed in a controlled laboratory environment, and each will perform the walking task three times. Data will be collected via Noraxon software during overground walking, including stance phase percentage, swing phase percentage, step duration (ms), double support duration (ms), and cadence (steps/min).

  5. Quality of Life (Nottingham Health Profile - NHP)

    Time frame: Baseline and post-intervention (8 weeks)

    Quality of life will be evaluated using the Nottingham Health Profile, covering six dimensions: physical mobility, pain, sleep, energy, social isolation, and emotional reactions.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Investigation of the Effectiveness of Exercise and Pain Neuroscience Education in Individuals With Chronic Nonspecific Low Back Pain With Central Sensitization

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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