Clinical trial NCT06847763: The Long Term Effects of Online Therapeutic Neuroscience Education in Patients With Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Mechanical
Chronic Pain
Keywords: therapeutic neuroscience education
chronic low back pain
kinesiophobia
disability
treatment expectation
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2025-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief 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). 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Kinesiophobia
timeFrame: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)
measure: Pain Level
timeFrame: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)
measure: Pain Catastrophizing
timeFrame: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)
Secondary outcomes:
measure: Disability
timeFrame: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)
measure: Physical Function
timeFrame: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)
measure: Treatment Expectation
timeFrame: T0 (baseline), T1 (3rd week)
measure: Treatment Satisfaction
timeFrame: T2 (6th week) and T3 (6 month follow up)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ornek Medical Clinic
state: Atasehir
Study officials:
affiliation: Marmara University
name: Mine Gulden Polat, Prof.
role: STUDY_DIRECTOR
References: