Chronic Non-specific Low Back PainNCT07249710
Pain Neuroscience Education in Physiotherapy Students With Chronic Non-Specific Low Back Pain
A study testing Pain Neuroscience Education (PNE) in people with Chronic Non-specific Low Back Pain and Physiotherapist Students, run by Ayşe ŞİMŞEK at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the immediate effects of a single-session Pain Neuroscience Education (PNE) program in physiotherapy students who experience chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-specific Low Back Pain, Physiotherapist Students
- What is being tested?
- Pain Neuroscience Education (PNE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Undergraduate physiotherapy and rehabilitation students
- Chronic non-specific low back pain for at least 3 months
- Pain intensity ≥3/10 on the Numeric Pain Rating Scale in the last week
- willing to participate
Who cannot join
- History of back surgery within the last 6 months
- Presence of neurological, orthopedic, cardiac, or systemic chronic disease
- Current participation in any physiotherapy, exercise, or medical treatment for low back pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabük University Faculty of Health Sciences
Karabük, 78050
About this study
Official title: Immediate Effects of Pain Neuroscience Education in Physiotherapy Students With Chronic Non-specific Low Back Pain: a Pre-Post Intervention Study
This study aims to examine the immediate effects of a single-session Pain Neuroscience Education (PNE) program in physiotherapy students who experience chronic non-specific low back pain. The PNE session focuses on explaining pain mechanisms, central sensitization, and the role of psychological, cognitive, and behavioral factors in chronic pain. Participants complete outcome measures assessing pain intensity, pain knowledge, pain catastrophizing, and kinesiophobia before and immediately after the intervention. The purpose of the study is to determine whether a brief educational session can produce immediate improvements in pain-related outcomes in a student population.
Read the detailed description
This study is a retrospective registration of a completed pre-post interventional study conducted among undergraduate physiotherapy students with chronic non-specific low back pain. The objective of the research was to evaluate the immediate effects of a single-session Pain Neuroscience Education (PNE) program on pain intensity, pain knowledge, pain-related beliefs, pain catastrophizing, and kinesiophobia.
The PNE session lasted approximately 70 minutes and was delivered by a physiotherapist trained in pain neuroscience and the biopsychosocial model. The session covered pain neurophysiology, the distinction between acute and chronic pain, central sensitization, factors contributing to persistent pain, and the role of cognition, emotions, and behaviors in pain experiences.
Participants completed self-report outcome measures at two time points:
Baseline (pre-intervention)
Immediately after the intervention
Outcome measures included the Numeric Pain Rating Scale (NPRS), Revised Neurophysiology of Pain Questionnaire (RNPQ), Pain Catastrophizing Scale (PCS), and Tampa Scale for Kinesiophobia (TSK). The study followed a single-group design with no control group and no randomization.
The study was conducted between April and October 2025 at Karabük University, Turkey. Ethical approval was obtained from the Karabük University Non-Interventional Clinical Research Ethics Committee (Decision No: 2025/2208), and written informed consent was obtained from all participants prior to data collection.
The results of this research aim to contribute to the understanding of how pain neuroscience education may provide immediate benefits in young adults experiencing chronic non-specific low back pain, particularly within a physiotherapy student population. The findings may support the integration of pain education approaches in physiotherapy curricula and early clinical training programs.
- Being tested
- Pain Neuroscience Education (PNE)
- Keywords
- low back pain, pain neuroscience education, physiotherapy, pain knowledge
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education (PNE)Behavioural
The program consists of a single 70-minute Pain Neuroscience Education (PNE) session, which includes explanations of pain neurophysiology, central sensitization, biopsychosocial pain concepts, and cognitive-behavioral factors influencing chronic pain. Delivered by a trained certified physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education Group | Experimental | Single-group intervention arm receiving a 70-minute Pain Neuroscience Education session. Outcome measures were collected at baseline and immediately after the intervention. Receives: Behavioral: Pain Neuroscience Education (PNE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Numeric Pain Rating Scale)
Pain intensity was measured using the Numeric Pain Rating Scale (NPRS), a 0-10 scale where higher scores indicate greater pain. Participants report their average low back pain in the last week. In the NPRS, individuals were asked to verbally rate the severity of their pain on a scale from 0 to 10. The minimum clinically significant difference for the NPRS was reported as 2 points.
Measured: Baseline and immediately after the intervention
Pain Knowledge (Revised Neurophysiology of Pain Questionnaire - rNPQ)
Pain knowledge was measured using the Revised Neurophysiology of Pain Questionnaire (rNPQ). Higher scores indicate deeper understanding of pain neurophysiology.
Measured: Baseline and immediately after the intervention
Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
Pain catastrophizing was measured using the Pain Catastrophizing Scale (PCS). The Likert-type scale consists of 13 items, with each item scored from 0 (strongly disagree) to 4 (strongly agree). The higher the total score, the higher the degree of negative and exaggerated thoughts about pain
Measured: Baseline and immediately after the intervention
Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
Kinesiophobia was assessed using the Tampa Scale for Kinesiophobia (TSK). Higher scores reflect greater fear of movement and reinjury. The TSK has a total of 17 items, and each item is scored using a 5-point Likert scale ranging from 1 = "disagree" to 4 = "strongly agree." The total score ranges from 17 to 68, with higher scores indicating greater fear of injury.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Apr 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe ŞİMŞEK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe ŞİMŞEK, Hacettepe University
- Investigators
- AYŞE ŞİMŞEK, MSc, Study director, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249710
- Sponsor's protocol ID
- KBU-2025-2208
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simsek A, Gunes M, Ozmen T, Ulger O. Immediate effects of pain neuroscience education in physiotherapy students with chronic non-specific low back pain: a single arm pre-post intervention study. BMC Med Educ. 2026 Feb 20;26(1):493. doi: 10.1186/s12909-026-08869-6.
PubMed 41721276
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Pain Neuroscience Education in Physiotherapy Students With Chronic Non-specific Low Back Pain: a Pre-Post Intervention Study
- ClinicalTrials.gov ID
- NCT07249710
- Acronym / sponsor ID
- KBU-2025-2208
- Keywords
- low back pain, pain neuroscience education, physiotherapy, pain knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ayşe ŞİMŞEKUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 25 Nov 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.
This study aims to examine the immediate effects of a single-session Pain Neuroscience Education (PNE) program in physiotherapy students who experience chronic non-specific low back pain. The PNE session focuses on explaining pain mechanisms, central sensitization, and the role of psychological, cognitive, and behavioral factors in chronic pain. Participants complete outcome measures assessing pain intensity, pain knowledge, pain catastrophizing, and kinesiophobia before and immediately after the intervention. The purpose of the study is to determine whether a brief educational session can produce immediate improvements in pain-related outcomes in a student population.
Detailed description
This study is a retrospective registration of a completed pre-post interventional study conducted among undergraduate physiotherapy students with chronic non-specific low back pain. The objective of the research was to evaluate the immediate effects of a single-session Pain Neuroscience Education (PNE) program on pain intensity, pain knowledge, pain-related beliefs, pain catastrophizing, and kinesiophobia.
The PNE session lasted approximately 70 minutes and was delivered by a physiotherapist trained in pain neuroscience and the biopsychosocial model. The session covered pain neurophysiology, the distinction between acute and chronic pain, central sensitization, factors contributing to persistent pain, and the role of cognition, emotions, and behaviors in pain experiences.
Participants completed self-report outcome measures at two time points:
Baseline (pre-intervention)
Immediately after the intervention
Outcome measures included the Numeric Pain Rating Scale (NPRS), Revised Neurophysiology of Pain Questionnaire (RNPQ), Pain Catastrophizing Scale (PCS), and Tampa Scale for Kinesiophobia (TSK). The study followed a single-group design with no control group and no randomization.
The study was conducted between April and October 2025 at Karabük University, Turkey. Ethical approval was obtained from the Karabük University Non-Interventional Clinical Research Ethics Committee (Decision No: 2025/2208), and written informed consent was obtained from all participants prior to data collection.
The results of this research aim to contribute to the understanding of how pain neuroscience education may provide immediate benefits in young adults experiencing chronic non-specific low back pain, particularly within a physiotherapy student population. The findings may support the integration of pain education approaches in physiotherapy curricula and early clinical training programs.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education Group | Experimental | Behavioral: Pain Neuroscience Education (PNE)Single-group intervention arm receiving a 70-minute Pain Neuroscience Education session. Outcome measures were collected at baseline and immediately after the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergraduate physiotherapy and rehabilitation students
- Chronic non-specific low back pain for at least 3 months
- Pain intensity ≥3/10 on the Numeric Pain Rating Scale in the last week
- willing to participate
Key exclusion criteria (3 listed)
- History of back surgery within the last 6 months
- Presence of neurological, orthopedic, cardiac, or systemic chronic disease
- Current participation in any physiotherapy, exercise, or medical treatment for low back pain
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 |
|---|---|---|
| Pain Neuroscience Education (PNE)The program consists of a single 70-minute Pain Neuroscience Education (PNE) session, which includes explanations of pain neurophysiology, central sensitization, biopsychosocial pain concepts, and cognitive-behavioral factors influencing chronic pain. Delivered by a trained certified physiotherapist. | Behavioural | Pain Neuroscience Education Group |
Primary outcome
Pain Intensity (Numeric Pain Rating Scale)
Time frame: Baseline and immediately after the intervention
Pain intensity was measured using the Numeric Pain Rating Scale (NPRS), a 0-10 scale where higher scores indicate greater pain. Participants report their average low back pain in the last week. In the NPRS, individuals were asked to verbally rate the severity of their pain on a scale from 0 to 10. The minimum clinically significant difference for the NPRS was reported as 2 points.
Pain Knowledge (Revised Neurophysiology of Pain Questionnaire - rNPQ)
Time frame: Baseline and immediately after the intervention
Pain knowledge was measured using the Revised Neurophysiology of Pain Questionnaire (rNPQ). Higher scores indicate deeper understanding of pain neurophysiology.
Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
Time frame: Baseline and immediately after the intervention
Pain catastrophizing was measured using the Pain Catastrophizing Scale (PCS). The Likert-type scale consists of 13 items, with each item scored from 0 (strongly disagree) to 4 (strongly agree). The higher the total score, the higher the degree of negative and exaggerated thoughts about pain
Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
Time frame: Baseline and immediately after the intervention
Kinesiophobia was assessed using the Tampa Scale for Kinesiophobia (TSK). Higher scores reflect greater fear of movement and reinjury. The TSK has a total of 17 items, and each item is scored using a 5-point Likert scale ranging from 1 = "disagree" to 4 = "strongly agree." The total score ranges from 17 to 68, with higher scores indicating greater fear of injury.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Derived from this study: PubMed 41721276Simsek A, Gunes M, Ozmen T, Ulger O. Immediate effects of pain neuroscience education in physiotherapy students with chronic non-specific low back pain: a single arm pre-post intervention study. BMC Med Educ. 2026 Feb 20;26(1):493. doi: 10.1186/s12909-026-08869-6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
AYŞE ŞİMŞEK, MSc study director
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education (PNE) in people with Chronic Non-specific Low Back Pain and Physiotherapist Students, run by Ayşe ŞİMŞEK at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 25 Nov 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numeric Pain Rating Scale) (time frame: Baseline and immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07249710, which also lists 1 linked publication.
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 25 Nov 2025.