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Adjunct Pain Neuroscience Education for Kinesiophobia in Chronic Low Back Pain: a Randomized Controlled Trial With Exploratory Resting-state fMRI
Sponsor study identifier
interventional
60
1 country
1
Study Start
January 6, 2025
Actual (reported)Primary Completion
October 15, 2025
Actual (reported)Study Completion
October 15, 2025
Actual (reported)\### What is this study about? This study looked at whether adding \*\*pain neuroscience education (PNE)\*\* to standard therapeutic exercise helps people with chronic low back pain who are afraid of moving (a condition called \*kinesiophobia\*). \### Why does it matter? Chronic low back pain is the leading cause of disability worldwide. Many people with chronic back pain develop fear of movement, which makes them avoid exercise and can slow down recovery. While exercise is the recommended first-line treatment, fear of movement often reduces how much patients benefit from it. Pain neuroscience education is a talking therapy that helps patients understand that chronic pain is not always a sign of tissue damage - it often involves the nervous system becoming overly sensitive. The idea is that changing how patients think about pain may reduce their fear and help them engage more fully in exercise. \### What did the researchers do? Patients with chronic low back pain and high fear of movement were randomly assigned to two groups
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2025
Actual (reported)October 15, 2025
Actual (reported)October 15, 2025
Actual (reported)September 25, 2026
Actual (reported)October 5, 2026
Actual (reported)TSK-17
TSK-17, full name Tampa Scale of Kinesiophobia-17, ranges from 17 to 68, and a higher score indicates worse kinesiophobia.
TSK-17 was administered at baseline, 8 weeks, 24 weeks.
Numerical Rating Scale
at baseline, 8 weeks, 24 weeks
Roland-Morris Disability Questionnaire
at baseline, 8 weeks, 24 weeks
Pain Catastrophizing Scale
at baseline, 8 weeks, 24 weeks
Central Sensitization Inventory
at baseline, 8 weeks, 24 weeks
Fractional amplitude of low-frequency fluctuations
at baseline, 8 weeks
\*\*Therapeutic Exercise (TE)\*\* is a structured, supervised program of physical activities designed to improve strength, flexibility, motor control, and functional capacity in patients with musculoskeletal conditions such as chronic low back pain. In this study, the TE program combined three components: motor control exercises (e.g., transversus abdominis and multifidus activation to stabilize the lumbar spine), stretching exercises (e.g., piriformis and erector spinae stretches), and low-intensity aerobic training (daily walking). It was delivered in two supervised face-to-face sessions (at baseline and week 4) with prescribed home exercises performed twice daily, and served as the active control condition that both study groups received-with the experimental group additionally receiving pain neuroscience education.
Qingdao Municipal Hospital
Qingdao, Shandong, 266001, China
60 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2026
First Posted
October 5, 2026
Study Start
January 6, 2025
Actual (reported)\*\*Pain Neuroscience Education (PNE)\*\* is a non-pharmacological, educational intervention that helps people with chronic pain reconceptualize their understanding of pain. Through structured discussions and visual materials, a trained therapist explains that chronic pain is often not a reliable sign of ongoing tissue damage but rather a result of heightened nervous system sensitivity, and that psychological factors such as fear, stress, and negative beliefs can amplify pain perception. The goal is to correct misconceptions about pain, reduce fear of movement (kinesiophobia), and encourage patients to engage more fully in exercise and rehabilitation-rather than directly treating pain through manual therapy, medication, or exercise itself.
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Primary Completion
October 15, 2025
Actual (reported)Study Completion
October 15, 2025
Actual (reported)Last Updated
October 5, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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