- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305597
Effects of Virtual Reality-Assisted Pain Neuroscience Education on Chronic Nonspecific Low Back Pain
Effects of Virtual Reality-Assisted Pain Neuroscience Education on Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Chronic nonspecific low back pain (CNSLBP) is a complex condition that cannot be explained solely by biomechanical factors and also involves psychological and neurocognitive components. Kinesiophobia, pain catastrophizing, and maladaptive pain beliefs have been shown to play a significant role in the chronification of pain and the increase in disability. Therefore, the Pain Neuroscience Education (PNE) approach, which focuses on the neurophysiology of pain, helps individuals reconceptualize pain, reduces fear-avoidance behaviors, and supports functional improvement. When applied in combination with exercise, PNE has been reported to provide additional benefits in reducing pain intensity, kinesiophobia, and catastrophizing. However, conventional educational methods may be limited in conveying abstract neurophysiological concepts.
At this point, virtual reality (VR) technology may enhance the effectiveness of pain education by providing an interactive and engaging learning environment. VR has been reported to facilitate cognitive restructuring in individuals with chronic pain and to increase motivation for participation. Moreover, VR-supported rehabilitation interventions have been shown to have short-term positive effects on pain and kinesiophobia in chronic pain conditions.
Core stabilization exercises are an effective method for improving postural control and functional stability in low back pain by regulating the activation of muscles surrounding the spine. However, purely physical approaches may be insufficient in adequately addressing the psychological dimensions of pain. Integrating VR-supported PNE into an exercise program may broaden the scope of rehabilitation by simultaneously influencing both biomechanical and cognitive processes. Therefore, this study aims to investigate the effects of adding VR-supported pain education to core stabilization exercises on pain, kinesiophobia, pain catastrophizing, functional status, and balance in individuals with CNSLBP. This holistic approach is expected to provide an innovative contribution to conventional exercise protocols and to shed light on the biopsychosocial management of chronic low back pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: İrem CANLI, Ph.D
- Phone Number: +905348377384
- Email: iremvalamur@gmail.com
Study Locations
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-
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Kırşehir, Turkey (Türkiye)
- Recruiting
- Kırşehir Ahi Evran University
-
Contact:
- Phone Number: +90 534 837 73 84
- Email: iremvalamur@gmail.com
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-
Kirşehi̇r
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Center, Kirşehi̇r, Turkey (Türkiye), 40100
- Not yet recruiting
- Kırşehir Ahi Evran University
-
Contact:
- İrem CANLI
- Phone Number: 05348377384
- Email: iremvalamur@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be between the ages of 18 and 65
- Have a diagnosis of nonspecific low back pain with a history of low back pain lasting at least 3 months
- Have no specific pathologies that could cause low back pain (e.g., tumor, infection, fracture, inflammatory disease)
- Be able to walk independently and have the capacity to exercise
- Mini Mental State Examination score >23
Exclusion Criteria:
- Individuals who have undergone lumbar surgery within the last year,
- Individuals with central or peripheral neurological disorders (e.g., multiple sclerosis, peripheral neuropathy, Parkinson's disease),
- Those with vestibular, visual, or balance disorders (those at risk of dizziness or nausea during virtual reality applications),
- Those with serious cardiopulmonary or systemic diseases,
- Those with psychiatric disorders or a diagnosis of severe depression, those who are pregnant
- Individuals with a history of dizziness, epilepsy, or visual disturbances associated with virtual reality use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core Stabilization + Classic Pain Neuroscience Education
Individuals in this group will undergo classical pain education (based on visual presentation or face-to-face instruction) along with core stabilization exercises targeting the muscles surrounding the spine. The exercises will be organized according to protocols reported in the literature as safe and effective and will include the following elements:
During the application process, participants will be provided with classic educational materials (e.g., verbal explanations or informative brochures) about the physiological basis of pain, movement safety, and exercise-related pain management. Thi |
Individuals in this group will undergo classical pain education (based on visual presentation or face-to-face instruction) along with core stabilization exercises targeting the muscles surrounding the spine. The exercises will be organized according to protocols reported in the literature as safe and effective and will include the following elements:
During the application process, participants will be provided with traditional educational materials (e.g., verbal explanations or informational brochures) on the physiological basis of pain, movement safety, and pain management related to exercise.
This training will not include virtual reality support.
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Experimental: Core Stabilization + Virtual Reality-Assisted Pain Neuroscience Education
Individuals in this group will receive SG-supported pain education in addition to the Group 1 protocol. Program details:
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Individuals in this group will undergo classical pain education (based on visual presentation or face-to-face instruction) along with core stabilization exercises targeting the muscles surrounding the spine. The exercises will be organized according to protocols reported in the literature as safe and effective and will include the following elements:
Details of the Virtual Reality-supported pain neuroscience education program:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Severity of Pain
Time Frame: 6 week
|
A visual analog scale will be used to assess patients' current pain intensity.
This scale is one of the most commonly used scales for assessing pain intensity during rest, activity, and at night.
The scale features a 10 cm line on which the patient can mark their pain intensity.
Patients are asked to indicate the degree of their pain intensity on the line, ranging from no pain (left side) to unbearable pain (right side).
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6 week
|
|
Functional Status
Time Frame: 6 week
|
The level of disability resulting from low back pain will be assessed using the Oswestry Disability Index (ODI).
The ODI was developed by Fairbank et al. in 1980, and its Turkish validity and reliability were established by Yakut et al.
The ODI is one of the most widely used instruments for determining the extent to which daily living activities and functional status are affected by pain in individuals with low back pain.
|
6 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 6 week
|
To determine the balance level of individuals with CNSLBP, the Biodex Balance System, which has been reported to be a reliable and valid assessment tool, will be used.
Balance assessment on the Biodex Balance System is performed separately under dynamic and static conditions.
The system consists of a balance platform that can tilt up to approximately 20° and has a 360° range of motion.
The platform moves in the mediolateral (M-L) and anteroposterior (A-P) directions.
Under dynamic conditions, the device calculates the degree of platform tilt, whereas under static conditions it measures deviations of the center of pressure.
The difficulty level of the test is adjusted by changing the surface stability of the platform.
On the balance platform, stability levels range from 12 (minimum stability) to 0 (maximum stability).
In this study, the surface stability was set at Level 6.
The Biodex Balance System quantifies balance loss using the average of the M-L and A-P scores, with higher scores
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6 week
|
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Pain Catastrophizing
Time Frame: 6 week
|
The Pain Catastrophizing Scale (PCS) is a 13-item questionnaire designed to assess the extent of catastrophic thoughts and feelings related to pain in individuals experiencing pain.
Each item is rated on a 5-point scale, with higher scores indicating greater levels of catastrophizing.
Subscale scores are calculated by summing the scores of the corresponding items, and the total score is obtained by summing all items.
PCS scores range from 0 to 52.
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6 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 23591230588=
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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