An interventional study of routine physiotherapy + traditional patient education and pain neuroscience education in Acute Low-back Pain, sponsored by Iran University of Medical Sciences. Recruiting at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Iran University of Medical Sciences · Not applicable, Interventional, and Treatment
Acute low back pain is one of the most common health problems in the world. Most people experience it at least once in their lives, and although many cases improve within a few weeks, a significant number of patients continue to struggle with pain, fear of movement, stress, and reduced daily function. These psychological factors-such as catastrophizing ("my back is damaged"), fear of movement ("if I move, it gets worse"), and avoidance behaviors-can slow recovery and increase the risk of the pain becoming chronic.
Pain Neuroscience Education (PNE) is a modern educational approach that teaches patients how pain actually works in the nervous system. Instead of focusing only on muscles and bones, PNE helps people understand how the brain interprets pain, why pain can persist even without serious injury, and how thoughts, emotions, and behaviors can influence the experience of pain. Research shows that PNE can reduce fear, improve movement, and help people participate better in rehabilitation-especially in chronic pain. However, there is very limited high-quality evidence about its effects in acute low back pain.
The purpose of this study is to determine whether adding Pain Neuroscience Education to routine physiotherapy can improve recovery in people with acute low back pain.
To do this, the investigators will conduct a single-blind randomized clinical trial with two groups of patients:
Control group: Receives conventional physiotherapy, including soft-tissue mobilization and TENS, along with routine patient education about posture and back care.
Intervention group: Receives the same physiotherapy plus two structured sessions of Pain Neuroscience Education, delivered individually using simple explanations, metaphors, and visual materials.
Both groups will receive eight treatment sessions over four weeks.
The investigators will measure several important outcomes before starting treatment and immediately after the 8th session, including:
Pain intensity
Functional disability
Pain catastrophizing
Fear-avoidance beliefs
Fear of movement (kinesiophobia)
The investigators' hypothesis is that patients who receive PNE in addition to routine physiotherapy will show greater reductions in pain, disability, fear, and catastrophizing compared to those receiving physiotherapy alone.
If proven effective, this approach could provide a simple, low-cost, and safe addition to physiotherapy that not only reduces pain but also prevents acute low back pain from turning into a chronic condition. This could help improve patients' quality of life and reduce the economic and healthcare burden caused by low back pain.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 48 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Iran University of Medical Sciences is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Other: routine physiotherapy + traditional patient education · Behavioral: pain neuroscience education
Other: routine physiotherapy + traditional patient education
Conventional Physiotherapy (Control Group) Participants in the control group will receive a baseline physiotherapy protocol, administered twice weekly for four weeks (8 sessions total). Each session includes: Soft Tissue Mobilization (40 minutes): Four specific myofascial release techniques targeting the low back and pelvic muscles (e.g., transverse sliding of lumbar muscles, thoracolumbar fascia release, quadratus lumborum release, iliopsoas release). Transcutaneous Electrical Nerve Stimulation (TENS) (30 minutes): Applied crosswise over the low back with parameters set at 100 Hz frequency and 300 µs pulse width, adjusted to a strong but comfortable sensory level. Additionally, this group receives two individual 50-minute sessions of standard physical hygiene and routine back care education to control for the time and attention given to the experimental group's Pain Neuroscience Education.
The experimental group receives the same conventional physiotherapy as the control group, with the addition of PNE. This consists of two individual, face-to-face educational sessions (40-50 minutes each), delivered before the first and after the last physiotherapy session. The curriculum is based on established resources ("Explain Pain" and "Pain Neuroscience Education: Teaching People About Pain") and uses metaphors, examples, and slides to reconceptualize pain by explaining neurobiology, central sensitization, and the distinction between pain and tissue injury. Understanding is assessed using the revised Neurophysiology of Pain Questionnaire (rNPQ), and participants receive a booklet for reinforced learning at home.
Visual Analog Scale
Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: first session (day 1), end of 8th session (4 weeks)
Oswestwry Disability Index
Functional disability was assessed using the Oswestry Disability Index (ODI), a questionnaire scored from 0 to 100%, where 0 indicates no disability and 100 indicates maximum disability. Higher scores reflect greater levels of disability.
Time frame: first session (day 1), end of 8th session (4 weeks)
Tampa Scale Of Kinesiophobia
Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK), a questionnaire with scores ranging from 17 to 68. Higher scores indicate greater fear of movement, with scores of 38 or above considered indicative of high kinesiophobia.
Time frame: first session (day 1), end of 8th session (4 weeks)
Fear Avoidance Beliefs Questionnaire
Fear-avoidance beliefs were assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ), which evaluates beliefs about how physical activity and work may affect pain and disability. The questionnaire consists of two subscales (physical activity and work), with higher scores indicating stronger fear-avoidance beliefs.
Time frame: first session (day 1), end of 8th session (4 weeks)
Pain Catastrophizing Scale
Pain catastrophizing was assessed using the Pain Catastrophizing Scale (PCS), a questionnaire with a total score ranging from 0 to 52. Higher scores indicate greater levels of catastrophic thinking related to pain.
Time frame: first session (day 1), end of 8th session (4 weeks)
Started Oct 2025 (actual). Primary completion is estimated for Apr 2026, 6 months after the start.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 6 months is below that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
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Iran University of Medical Sciences