Chronic Non-specific Low Back PainNCT07202533
Pain Neuroscience Education and Exercise for Chronic Nonspecific Low Back Pain
A study testing Pain Neuroscience Education in people with Chronic Non-specific Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- Pain Neuroscience Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Aug 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals with radicular symptoms or cauda equina syndrome
- Severe osteoporosis
- Spondyloarthropathy
- Spondylolisthesis
- Lumbar spinal stenosis
- Lumbar fractures
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Karabük Province, 06100
About this study
Official title: Investigation of the Effectiveness of Exercise and Pain Neuroscience Education in Individuals With Chronic Nonspecific Low Back Pain With Central Sensitization
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.
Read the 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
- Chronic Non-specific Low Back Pain
- Being tested
- Motor Control Exercises, Pain Neuroscience Education
- Keywords
- low back pain, central sensitization, surface electromyography, pain neuroscience education, motor control exercise
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Control ExercisesOther
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 EducationOther
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.
Motor Control ExercisesOther
Participants will perform these exercises under physiotherapist supervision twice per week for 8 weeks. Exercises focus on improving deep trunk muscle coordination and stability.
| Study group | Role | What they receive |
|---|---|---|
| Motor Control Exercises | Active comparator | This group will receive motor control exercises only. Receives: Other: Motor Control Exercises |
| Motor Control Exercises + Pain Neuroscience Education | Experimental | 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. Receives: Other: Pain Neuroscience Education; Other: Motor Control Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Numerical Pain Rating Scale - NPRS)
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.
Measured: Baseline and post-intervention (8 weeks)
Pressure Paın Threshold Measurement
PPT will be measured using a digital algometer on the lumbar region. Higher values indicate reduced pain sensitivity.
Measured: Baseline and post-intervention (8 weeks)
Central Sensitization (Central Sensitization Inventory - CSI)
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.
Measured: Baseline and post-intervention (8 weeks)
Pain Knowledge (Revised Neurophysiology of Pain Questionnaire - rNPQ)
Participants' knowledge about pain neurophysiology will be assessed. The number of correct responses will be calculated.
Measured: Baseline and post-intervention (8 weeks)
Disability (Roland-Morris Disability Questionnaire - RMDQ)
Functional disability due to low back pain will be assessed using the RMDQ, a 24-item self-report questionnaire.
Measured: Baseline and post-intervention (8 weeks)
Muscle Activation (Surface EMG Analysis)
Surface EMG will evaluate activation levels of bilateral external oblique, internal oblique, transversus abdominis, and tibialis anterior muscles during gait.
Measured: Baseline and post-intervention (8 weeks)
Secondary outcomes (5)
Kinesiophobia (Tampa Scale for Kinesiophobia - TSK)
Fear of movement will be evaluated with the TSK. Total scores range from 17-68. Higher scores represent more fear-avoidance behavior.
Measured: Baseline and post-intervention (8 weeks)
Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
Total PCS scores will be used to assess exaggerated negative thoughts related to pain. Higher scores indicate greater catastrophizing.
Measured: Baseline and post-intervention (8 weeks)
Gait Analysis (OptoGait Photocell System)
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.
Measured: Baseline and post-intervention (8 weeks)
Gait Analysis (Noraxon Ultium Insole)
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).
Measured: Baseline and post-intervention (8 weeks)
Quality of Life (Nottingham Health Profile - NHP)
Quality of life will be evaluated using the Nottingham Health Profile, covering six dimensions: physical mobility, pain, sleep, energy, social isolation, and emotional reactions.
Measured: Baseline and post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start29 Aug 2024
- Primary completion8 Aug 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either a control group receiving motor control exercises or an intervention group receiving motor control exercises plus PNE. Both groups will receive treatment twice weekly for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe ŞİMŞEK, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202533
- Sponsor's protocol ID
- Hacettepe-FTR-AŞ-01
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Exercise and Pain Neuroscience Education in Individuals With Chronic Nonspecific Low Back Pain With Central Sensitization
- ClinicalTrials.gov ID
- NCT07202533
- Acronym / sponsor ID
- Hacettepe-FTR-AŞ-01
- Conditions
- Chronic Non-specific Low Back Pain
- Keywords
- low back pain, central sensitization, surface electromyography, pain neuroscience education, motor control exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either a control group receiving motor control exercises or an intervention group receiving motor control exercises plus PNE. Both groups will receive treatment twice weekly for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Motor Control Exercises | Active comparator | Other: Motor Control ExercisesThis group will receive motor control exercises only. |
| Motor Control Exercises + Pain Neuroscience Education | Experimental | Other: Pain Neuroscience Education, Other: Motor Control ExercisesThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Individuals with radicular symptoms or cauda equina syndrome
- Severe osteoporosis
- Spondyloarthropathy
- Spondylolisthesis
- Lumbar spinal stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor 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. | Other | Motor Control Exercises |
| Pain 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. | Other | Motor Control Exercises + Pain Neuroscience Education |
| Motor 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. | Other | Motor Control Exercises + Pain Neuroscience Education |
Primary outcome
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.
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.
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.
5 secondary outcomes
Kinesiophobia (Tampa Scale for Kinesiophobia - TSK)
Time frame: Baseline and post-intervention (8 weeks)
Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
Time frame: Baseline and post-intervention (8 weeks)
Gait Analysis (OptoGait Photocell System)
Time frame: Baseline and post-intervention (8 weeks)
Gait Analysis (Noraxon Ultium Insole)
Time frame: Baseline and post-intervention (8 weeks)
Quality of Life (Nottingham Health Profile - NHP)
Time frame: Baseline and post-intervention (8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education in people with Chronic Non-specific Low Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numerical Pain Rating Scale - NPRS) (time frame: Baseline and post-intervention (8 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.