Acute Low-back PainNCT07277517
The Effect of Integrating Pain Neuroscience Education(PNE) With Conventional Physiotherapy on Pain and Functional Disability in Patients With Acute Low Back Pain
A study testing routine physiotherapy + traditional patient education and pain neuroscience education in people with Acute Low-back Pain, run by Iran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Low-back Pain
- What is being tested?
- routine physiotherapy + traditional patient education and pain neuroscience education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- 5 Oct 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
rehabilitation facility, Iran university of medical science
Tehran
Pourahmadi, 00989122245593, pourahmadipt@gmail.com
About this study
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.
Read more
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
- Being tested
- routine physiotherapy + traditional patient education, pain neuroscience education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine physiotherapy + traditional patient educationOther
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.
pain neuroscience educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| "Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)" | Experimental | Not described Receives: Other: routine physiotherapy + traditional patient education; Behavioral: pain neuroscience education |
| "Conventional Physiotherapy With Routine Back-Care Education" | Active comparator | Not described Receives: Other: routine physiotherapy + traditional patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: first session (day 1), end of 8th session (4 weeks)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: first session (day 1), end of 8th session (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start5 Oct 2025
- Primary completionApr 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277517
- Sponsor's protocol ID
- IR.IUMS.REC.1404.530
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Integrating Pain Neuroscience Education(PNE) With Conventional Physiotherapy on Pain and Functional Disability in Patients With Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT07277517
- Acronym / sponsor ID
- IR.IUMS.REC.1404.530
- Conditions
- Acute Low-back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine physiotherapy + traditional patient educationConventional 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. | Other | "Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)", "Conventional Physiotherapy With Routine Back-Care Education" |
| pain neuroscience educationThe 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. | Behavioural | "Conventional Physiotherapy Plus Pain Neuroscience Education (PNE)" |
Primary outcome
Visual Analog Scale
Time frame: first session (day 1), end of 8th session (4 weeks)
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.
Oswestwry Disability Index
Time frame: first session (day 1), end of 8th session (4 weeks)
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.
3 secondary outcomes
Tampa Scale Of Kinesiophobia
Time frame: first session (day 1), end of 8th session (4 weeks)
Fear Avoidance Beliefs Questionnaire
Time frame: first session (day 1), end of 8th session (4 weeks)
Pain Catastrophizing Scale
Time frame: first session (day 1), end of 8th session (4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine physiotherapy + traditional patient education and pain neuroscience education in people with Acute Low-back Pain, run by Iran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammadreza Pourahmadi (00989122245593, pourahmadipt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: first session (day 1), end of 8th session (4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.