An interventional study of Pain Neuroscience Education and Neuromuscular Exercise in Low Back Pain, Chronic Low Back Pain and Central Sensitization, sponsored by Izmir Katip Celebi University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment
The goal of this randomized controlled study is to evaluate the effectiveness of pain neuroscience education (PNE) combined with neuromuscular exercises (NME) in individuals with chronic low back pain and central sensitization, and to compare the effects of this combined intervention with NME alone.
The main questions it aims to answer are:
Researchers will evaluate changes in pain and functional outcomes from baseline to post-intervention in both the PNE+NME and NME groups. Changes in outcomes will then be compared between the two groups to determine whether adding PNE to NME affects pain and functional outcomes compared with NME alone.
Participants will:
Chronic low back pain (CLBP) is a common musculoskeletal condition that can lead to persistent pain, poor functional and psychosocial outcomes. Central sensitization (CS) is present in a subgroup of individuals with CLBP and may contribute to poorer outcomes and greater clinical complexity.
Pain neuroscience education (PNE) aims to improve individuals' understanding of pain mechanisms and modify maladaptive pain-related beliefs. Neuromuscular exercises (NME) aim to improve motor control, muscle function, balance, coordination, and physical function.
This study will investigate the effectiveness of pain neuroscience education (PNE) combined with neuromuscular exercises (NME) in individuals with chronic low back pain and central sensitization and compare the effects of this combined intervention with NME alone.
After eligibility is confirmed and written informed consent is obtained, participants will be randomly assigned to either the NME group or the PNE+NME group. Both groups will participate in an 8-week exercise program with two sessions per week. The PNE+NME group will receive PNE in addition to NME.
At baseline, sociodemographic characteristics, including age, sex, height, weight, body mass index, occupation, medical history, and family history, and health-related habits, including smoking, alcohol consumption, and exercise habits, will be recorded.
The following outcomes will be assessed at baseline and after the 8-week intervention: central sensitization using the Central Sensitization Inventory; pain intensity using the Visual Analog Scale; pressure pain threshold using a pressure algometer; conditioned pain modulation; temporal summation; pain neuroscience knowledge using the Pain Neurophysiology Questionnaire; kinesiophobia using the Tampa Scale for Kinesiophobia; pain catastrophizing using the Pain Catastrophizing Scale; patient-reported physical function using the Oswestry Disability Index; performance-based physical function using the 30-Second Sit-to-Stand Test; body awareness using the Fremantle Back Awareness Questionnaire; spinal structure and mobility using the Hocoma-Valedo®Shape; trunk muscle endurance using the McGill protocol; balance using the ProKin 252 (Tecnobody); and sleep quality using the Single-Item Sleep Quality Scale.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Izmir Katip Celebi University is the lead sponsor of 192 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive pain neuroscience education (PNE) and neuromuscular exercise (NME).
Behavioral: Pain Neuroscience Education · Behavioral: Neuromuscular Exercise
Participants will receive neuromuscular exercise (NME).
Behavioral: Neuromuscular Exercise
Participants will receive pain neuroscience education (PNE) and neuromuscular exercise (NME) twice weekly for 8 weeks. Each session will last approximately 30-40 minutes.
Participants will receive neuromuscular exercise (NME) twice weekly for 8 weeks. Each session will last approximately 30-40 minutes.
Pain intensity
Visual Analog Scale (VAS)
Time frame: At baseline and after the 8-week intervention
Central sensitization
Central Sensitization Inventory (CSI)
Time frame: At baseline and after the 8-week intervention
Pressure pain threshold
Pressure algometer
Time frame: At baseline and after the 8-week intervention
Conditioned pain modulation
Conditioned pain modulation will be assessed using pressure pain thresholds before and after ischemic conditioning with an upper-arm cuff.
Time frame: At baseline and after the 8-week intervention
Temporal summation
Temporal summation will be assessed using repeated pressure stimuli delivered with a pressure algometer. Pain intensity after the first and tenth stimuli will be recorded using the Visual Analog Scale (VAS).
Time frame: At baseline and after the 8-week intervention
Pain neuroscience knowledge
Revised Neurophysiology of Pain Questionnaire (RNPQ)
Time frame: At baseline and after the 8-week intervention
Kinesiophobia
Tampa Scale for Kinesiophobia (TSK)
Time frame: At baseline and after the 8-week intervention
Pain catastrophizing
Pain Catastrophizing Scale (PCS)
Time frame: At baseline and after the 8-week intervention
Body awareness
Fremantle Back Awareness Questionnaire (FreBAQ)
Time frame: At baseline and after the 8-week intervention
Disability
Oswestry Disability Index (ODI)
Time frame: At baseline and after the 8-week intervention
Performance-based physical function
30-Second Sit-to-Stand Test (30 s- STS)
Time frame: At baseline and after the 8-week intervention
Spinal structure and mobility
Hocoma-Valedo®Shape
Time frame: At baseline and after the 8-week intervention
Trunk muscle endurance
McGill trunk endurance test
Time frame: At baseline and after the 8-week intervention
Balance
ProKin 252 (Tecnobody)
Time frame: At baseline and after the 8-week intervention
Sleep quality
Single-Item Sleep Quality Scale
Time frame: At baseline and after the 8-week intervention
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Izmir Katip Celebi University