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Low Back Pain, MechanicalNCT06847763

The Long Term Effects of Online Therapeutic Neuroscience Education in Patients With Chronic Low Back Pain

A study testing Therapeutic Neuroscience Education and Conventional Program in people with Low Back Pain, Mechanical and Chronic Pain, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the effects of online Therapeutic Neuroscience Education (TNE) combined with a 6-week conventional physiotherapy program on pain, disability, kinesiophobia, functionality, treatment expectations, and satisfaction in individuals with chronic low back pain (CLBP). Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain, Mechanical, Chronic Pain
What is being tested?
Therapeutic Neuroscience Education and Conventional Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2026to 1 Oct 2026
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 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Individuals aged 20-60
  • Literate
  • Having received a score of 24 or above in the Mini-Mental Status Assessment
  • Having internet access
  • Having back pain for more than 3 months
  • Having pain between 3-8 on the Numerical Pain Scale
  • Individuals with chronic back pain whose symptoms are not radicular

Who cannot join

  • Having other orthopedic/neurological disorders that will affect the evaluation and treatment
  • Patients with vertebral compression fractures on MRI and lumbar radiography
  • Patients with unstable neurological findings
  • Patients using analgesic medication during treatment
  • Patients with rheumatological and inflammatory diseases
  • Patients with acute trauma
  • Patients who are pregnant
  • Patients who have undergone lumbar region surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ornek Medical Clinic

    Istanbul, Atasehir, 34704

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Online Therapeutic Neuroscience Education Added to Conventional Physiotherapy Program on Clinical Outcomes, Treatment Expectations and Satisfaction Levels in Patients With Chronic Low Back Pain

This study aims to evaluate the effects of online Therapeutic Neuroscience Education (TNE) combined with a 6-week conventional physiotherapy program on pain, disability, kinesiophobia, functionality, treatment expectations, and satisfaction in individuals with chronic low back pain (CLBP). The goal is to improve participants' understanding of chronic pain, reduce fear and avoidance behaviors, enhance movement and functionality, and increase treatment satisfaction. The study also seeks to provide a lasting educational resource.

TNE focuses on educating patients about pain neurophysiology, aiming to reduce pain, improve function, and shift perceptions about pain through interactive sessions involving diagrams, metaphors, and examples. Despite evidence supporting TNE's effectiveness for chronic pain conditions, no studies have evaluated its online application or long-term effects.

Read more

The study will include 60 volunteers with CLBP (ages 20-60), randomized into two groups: one receiving conventional physiotherapy and online TNE, and the other receiving conventional treatment alone. The TNE group will participate in six weekly 45-minute online sessions, covering topics like pain neurophysiology, biopsychosocial factors, and pain coping strategies, without addressing anatomical or emotional aspects.

Educational materials, including resources adapted from "Why You Hurt" will be presented to the TNE group. Conventional physiotherapy includes hot packs, ultrasound, TENS, and home exercises for both groups.

Clinical outcomes will be assessed by a blinded researcher at multiple time points using tools such as pain and disability scales, kinesiophobia measures, functional tests, and questionnaires on treatment expectations and satisfaction. The study is significant for its innovative approach in examining the clinical and long-term effectiveness of online TNE as part of CLBP management.

Read the detailed description

The aim of this study is to determine the effects of therapeutic neuroscience education applied online in addition to a 6-week conventional physiotherapy program on pain, disability, kinesiophobia, functionality, treatment expectations and satisfaction in individuals with chronic low back pain.

At the end of the study, it is aimed to help individuals with chronic low back pain better understand the biological process underlying chronic pain conditions with therapeutic neuroscience education; to increase treatment expectations and satisfaction by achieving therapeutic effects such as reducing fear associated with pain and musculoskeletal injuries, and increasing movement and functionality.

In individuals with chronic low back pain, the disease state, fear and avoidance behavior related to the treatment process, catastrophizing, inappropriate beliefs and psychosocial factors (yellow flags) cause pain to increase and become chronic.

Therapeutic Neuroscience Education (TNE) is an information application applied by a physiotherapist with therapeutic purposes such as reducing pain, improving function, helping the individual understand the cause of their pain, and reconceptualizing pain. It is used to raise awareness about pain and the coding of pain in the brain, to improve the individual's health behavior and health status, and to stimulate the cognitive infrastructure. TNE is a method applied in the form of one-on-one seminar format, focused on pain neurophysiology, and in the form of speaking sessions. Within the scope of these speaking sessions, pictures, diagrams, graphs, examples, metaphors, and homework assignments explaining the neurophysiology of pain are used.

There are findings that Therapeutic Neuroscience Education improves pain and disability in various populations with chronic pain (such as low back/neck pain, fibromyalgia), but there is no protocol in the literature showing the effectiveness of the TNE program given online.

The importance of this study is that it will be an innovative study examining the effectiveness of online TNE, in addition to conventional physiotherapy programs, on clinical outcomes in individuals with chronic low back pain, as well as individuals' treatment expectations and satisfaction.

60 volunteers with chronic low back pain between the ages of 20-60 will be included in the study. Participants will be randomly assigned to Online TNE (n=30) and Control (n=30) groups that will receive conventional treatment according to an internet-based randomization program.

The online training modules to be used in the first phase of the study will be structured specifically for individuals with chronic low back pain. The training program will be created in 6 sessions lasting 45 minutes in total and one session for a week.

Within the scope of TNE training; chronic pain, pain and injury are not equivalent, pain is an output produced in the brain rather than an input, biopsychosocial factors, neurophysiology of pain, nociception and nociceptive pathways, neurons, synapses, action potential, spinal inhibition and facilitation, sensitization, extra sensitive nerves and alarm system, stress, fear, avoidance and effects on pain, plasticity of the nervous system, pain coping strategies and effects of movement on chronic pain will be discussed with metaphors and stories. Anatomical and pathoanatomical models will not be addressed, and emotional or behavioral aspects of pain will not be included.

Participants in the TNE group will be presented with illustrated cards as training materials, including various examples, metaphors, and assignments developed to facilitate individual understanding.

In the second phase of the study, the effectiveness of the online education program will be evaluated. In addition to the conventional physiotherapy program, the TNE group will be provided with one session of therapeutic neuroscience education online for six weeks. The password-protected zoom platform will be used for online education. The conventional physiotherapy program will be given all participants and included hot pack, ultrasound, TENS and a standard home exercise program to strengthen the abdominal and back muscles.

The participants will be evaluated by an independent researcher at baseline, in the third week, at the 6th week and 6 months after the study in a blinded manner.

Participants' pain will be assessed with the Numeric Pain Scale and Pain Catastrophizing Scale, fear and anxiety related to movement with the Tampa Scale of Kinesiophobia, and disabilities with the Roland Morris Disability Questionnaire and Timed Up and Go Test. The flexibility of the lumbar extensors will be measured by the forward bending distance. Treatment Expectations will be assessed with the Treatment Expectation Questionnaire at the beginning and middle of the program, and treatment satisfaction will be assessed with the Patient Satisfaction Scale in Physiotherapy.

Being tested
Therapeutic Neuroscience Education, Conventional Program
Keywords
therapeutic neuroscience education, chronic low back pain, kinesiophobia, disability, treatment expectation
Medical subject headings
Low Back Pain, Chronic Pain, Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic Neuroscience EducationOther

    Therapeutic Neuroscience Education applied in the form of one-on-one seminar format, focused on pain neurophysiology, and in the form of speaking sessions. Within the scope of these speaking sessions, pictures, diagrams, graphs, examples, metaphors, and homework assignments explaining the neurophysiology of pain are used.

  • Conventional ProgramOther

    Conventional physiotherapy includes hot packs (20 minutes), ultrasound (1 mHz frequency, 1,5 watt/cm², 5 minutes left/right lumbar region), TENS (100Hz, 20 minutes), and home exercises.

Study groups in NCT06847763
Study groupRoleWhat they receive
ExperimentalExperimentalThese participants will receive online Therapeutic Neuroscience Education with conventional physiotherapy program.
Receives: Other: Therapeutic Neuroscience Education; Other: Conventional Program
ControlActive comparatorControl group will receive only conventional physiotherapy program.
Receives: Other: Conventional Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kinesiophobia

    Tampa Scale of Kinesiophobia will be used to assess kinesiophobia, which is an anxiety state that develops against activity and physical movement. This scale was developed to distinguish between non-excessive fear and phobia in individuals with chronic musculoskeletal pain. It is widely used in the literature to assess fear and anxiety related to movement. The scale consists of 17 items covering work-related activities, injury, re-injury, and fear-avoidance parameters and scored between 17-68. High scores obtained from the scale indicate that the individual's level of kinesiophobia has increased. Studies conducted on patients with low back and neck pain have revealed that the test-retest reliability ICC value of the Turkish version of the scale is 0.80.

    Measured: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)

  2. Pain Level

    Numeric Pain Scale will be used for assessing the participants' pain levels. Participants will be asked to determine the number that best describes their pain on a scale of 0 to 10, where 0 = no pain and 10 = unbearable pain. The Numerical Pain Scale is a valid and reliable measurement method for subjective pain intensity assessment. Rest, activity and night pain will be located on a horizontal stripe that the participant will mark. High numbers indicated higher pain levels.

    Measured: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)

  3. Pain Catastrophizing

    The Pain Catastrophizing Scale will be used to assess participants' pain catastrophizing. This scale is a self-report questionnaire that assesses unhelpful coping strategies and catastrophizing thoughts about pain and injury and has strong validity and reliability. The scale consists of 13 questions, each question is scored between 0 and 4. The lowest possible score is 0, the highest score is 52. As the score increases (e.g. >10), pain catastrophizing thoughts increase. The Turkish validity and reliability study of the questionnaire was conducted and Cronbach's alpha value was reported as 0.955 and ICC value as 0.830.

    Measured: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)

Secondary outcomes (4)
  1. Disability

    The Roland Morris Disability Questionnaire will be used to determine the physical adequacy level of the participants. The questionnaire consists of 24 items and yes/no answers are given for each activity. A yes answer is scored as 1 point, a no answer as 0 points. The lowest score on this scale is 0, and the highest score is 24. High scores indicate inadequacy in physical activities. The Turkish validity and reliability study of the questionnaire was conducted and the Cronbach alpha internal consistency value was reported as over 0.85.

    Measured: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)

  2. Physical Function

    The Timed Up and Go Test will be used to assess functional status. This performance test covers basic motor skills such as static balance, dynamic balance, mobility and turning. During the test, the individual will get up from a seated position, walk a distance of 3 meters, return and sit down again. The test duration will be measured in seconds and recorded.The validity and reliability of the test in individuals with chronic low back pain has been proven.

    Measured: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)

  3. Treatment Expectation

    Participants' treatment expectation levels will be assessed with the Treatment Expectations Questionnaire. The questionnaire, consisting of 15 main items, is in the form of a scale where the individual marks his/her treatment expectation between 0 and 10. The cumulative score of the questionnaire is 150 and the internal consistency Cronbach's alpha value of the original version was reported as 0.79 and the test-retest reliability was high (0.76). The Turkish validity and reliability of the questionnaire was conducted and the internal consistency Cronbach's alpha value was reported as 0.832.

    Measured: T0 (baseline), T1 (3rd week)

  4. Treatment Satisfaction

    Participants' treatment satisfaction will be evaluated with a subjective mini-survey in 5-point Likert form prepared by the researchers. Treatment satisfaction will be scored between 5-25.

    Measured: T2 (6th week) and T3 (6 month follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start1 Feb 2026
  3. Primary completion1 Oct 2026
  4. Study completion1 Oct 2026

Resources

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
Model description
Randomized controlled study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06847763
Sponsor's protocol ID
IstanbulBUFC8
Status last verified
Oct 2026
First submitted
21 Feb 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Neuroscience Education and Conventional Program in people with Low Back Pain, Mechanical and Chronic Pain, run by Istanbul Bilgi University 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 7 inclusion and 8 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 26 Oct 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 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?

Kinesiophobia (time frame: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)). The study lists 3 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 26 Oct 2026.

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