The Long Term Effects of Online Therapeutic Neuroscience Education in Patients With Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorIstanbul Bilgi University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals aged 20-60
Literate
Having received a score of 24 or above in the Mini-Mental Status Assessment
Having internet access
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic Neuroscience Education
Other interventionTherapeutic 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 Program
Other interventionConventional 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
T2 (6th week) and T3 (6 month follow up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istanbul Bilgi University
Lead sponsor
Marmara University
Collaborator
Source ClinicalTrials.gov