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

NCT07277517 | Recruiting

• 1 other identifier: IR.IUMS.REC.1404.530
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Low-back Pain

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  pain intensity which will be measured by Visual Analog Scale The scale is from 0 to 10. The closer the number is to 10, the more severe the pain is.

  first session (day 1), end of 8th session (4 weeks)

• Oswestwry Disability Index

  functional disability which will be measured by Oswestry Disability Index The scale is from 0 to 100 percentage. The closer the number is to 100, the more severe is the disability level.

  first session (day 1), end of 8th session (4 weeks)

Secondary Outcomes (3)

• Tampa Scale Of Kinesiophobia

  first session (day 1), end of 8th session (4 weeks)

• Fear Avoidance Beliefs Questionnaire

  first session (day 1), end of 8th session (4 weeks)

• Pain Catastrophizing Scale

  first session (day 1), end of 8th session (4 weeks)

Study Arms (2)

"Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)"

EXPERIMENTAL

Other: routine physiotherapy + traditional patient education; Behavioral: pain neuroscience education

"Conventional Physiotherapy With Routine Back-Care Education"

ACTIVE COMPARATOR

Other: routine physiotherapy + traditional patient education

Interventions

routine physiotherapy + traditional patient education OTHER

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.

"Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)"; "Conventional Physiotherapy With Routine Back-Care Education"

pain neuroscience education BEHAVIORAL

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.

"Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (1)

rehabilitation facility, Iran university of medical science

Tehran, Iran

RECRUITING

Central Study Contacts

Mohammadreza Pourahmadi

CONTACT

00989122245593; pourahmadipt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 11, 2025
• Study Start: October 5, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-10

Locations

IR (1)