The Effect of Integrating Pain Neuroscience Education(PNE) With Conventional Physiotherapy on Pain and Functional Disability in Patients With Acute Low Back Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Low-back Pain
• Intervention / Treatment: Other: routine physiotherapy + traditional patient education; Behavioral: pain neuroscience education

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammadreza Pourahmadi; Phone Number: 00989122245593; Email: pourahmadipt@gmail.com

Study Locations

• Iran
  • Tehran, Iran
    • Recruiting
    • rehabilitation facility, Iran university of medical science
    • Contact: Pourahmadi; Phone Number: 00989122245593; Email: pourahmadipt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years and older.
• A primary complaint of acute low back pain (defined as pain between the bottom of the ribs and the gluteal fold), with or without leg pain.
• Pain duration of less than 6 weeks.
• Absence of any "red flags" for serious spinal pathology (e.g., tumor, infection, fracture, cauda equina syndrome), as confirmed by an orthopedist or neurologist.

Exclusion Criteria:

• Low back pain lasting more than 3 months (chronic low back pain).
• History of spinal surgery within the past 3 years.
• Inability to read or understand Persian.
• Diagnosed cognitive impairments.
• Unwillingness to continue the treatment or study protocol.
• Diagnosed rheumatic, neurological, cardiac, metabolic, or respiratory diseases.
• Diagnosis of fibromyalgia, chronic fatigue syndrome, loss of skin sensation, or skin inflammation/swelling in the low back area.
• Presence or emergence of any "red flag" condition.
• Missing more than 3 consecutive treatment sessions.
• Previous participation in Pain Neuroscience Education sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)"	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.; Behavioral: 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.
Active Comparator: "Conventional Physiotherapy With Routine Back-Care 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	first session (day 1), end of 8th session (4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	first session (day 1), end of 8th session (4 weeks)

Collaborators and Investigators

• Sponsor: Iran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 29, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IR.IUMS.REC.1404.530

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No