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

NCT06847763 | Recruiting

• 1 other identifier: IstanbulBUFC8
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Low Back Pain, Mechanical

Keywords

therapeutic neuroscience education; chronic low back pain; kinesiophobia; disability; treatment expectation

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (4)

• Disability

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

• Physical Function

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

• Treatment Expectation

  T0 (baseline), T1 (3rd week)

• Treatment Satisfaction

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

Study Arms (2)

Experimental

EXPERIMENTAL

These participants will receive online Therapeutic Neuroscience Education with conventional physiotherapy program.

Other: Therapeutic Neuroscience Education; Other: Conventional Program

Control

ACTIVE COMPARATOR

Control group will receive only conventional physiotherapy program.

Other: Conventional Program

Interventions

Therapeutic Neuroscience Education OTHER

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.

Experimental

Conventional Program OTHER

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.

Control; Experimental

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: collaborator
• Istanbul Bilgi University: lead

Study Sites (1)

Ornek Medical Clinic

Istanbul, Atasehir, 34704, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Mine Gulden Polat, Prof.

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Mine Gulden Polat, Prof.

CONTACT

90053 251 3686; guldenpolat2002@yahoo.com

Furkan Cakir, MSc.

CONTACT

905426033944; fztfurkancakir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)