Central Sensitization, Chronic Low Back Pain (CLBP), Fear of Movement, Kinesiophobia, Virtual Reality
Conditions
Brief summary
The goal of this clinical trial is to learn if an immersive virtual reality (VR) exercise program can help reduce back pain and improve physical function and psychological well-being in adults with chronic low back pain. The main questions it aim to answer are * Does the virtual reality (VR) exercise reduce back pain? * Does it lead to positive changes in how participants perceive pain? * Does it improve back flexibility and reduce disability in daily activities? * Does it help reduce the fear of movement and negative thoughts related to pain? Method Wear a Meta Quest 3s device and participate in a 15-minute virtual reality exercise program called 'FitXR'. Be evaluated for their back pain, sensory test, range of motion, and level of disability in daily life before and after the exercise program. Complete questionnaires about their thoughts and feelings regarding their pain and movement.
Interventions
BEHAVIORALImmersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s)
participants assigned to the intervention group will perform a 15-minute immersive virtual reality (VR) exercise program using the FitXR application on the Meta Quest 3s headset. This program provides interactive, visually immersive exercise tasks designed to engage participants in physical activity while reducing fear of movement and enhancing functional recovery.
BEHAVIORALConventional Exercise Program (Matched Exercise, without VR)
Participants assigned to this arm will perform the same 15-minute exercise program without virtual reality equipment. This allows comparison between immersive VR-based exercise and conventional exercise of equivalent intensity and duration.
Sponsors
dongmin kang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to one of two parallel groups. The experimental group will perform immersive Virtual Reality-based exercise using the FitXR application, while the control group will perform the same exercise protocol without VR immersion. Both groups will receive 15-minute exercise sessions over the study period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-40 years. * Non-specific chronic low back pain lasting ≥3 months. * Baseline pain intensity VAS ≥4/10. * Kinesiophobia (TSK-13) ≥34. * Able to perform physical activity using immersive VR (screened as suitable for head-mounted display-based activity). * Understands the study purpose and procedures and provides written informed consent.
Exclusion criteria
* Severe pain making participation infeasible: VAS ≥8/10. * Lumbar spine surgery within the past 6 months. * Severe musculoskeletal disorders (e.g., advanced osteoarthritis, pathological vertebral fracture). * Neurological disorders (e.g., multiple sclerosis, Parkinson's disease, stroke). * Cardiovascular disease (e.g., heart failure, clinically significant arrhythmia, recent myocardial infarction). * Simulator Sickness Questionnaire (SSQ): total score ≥20 or any single item scored 3. * Vulnerable populations excluded: minors, older adults, individuals with psychiatric disorders or cognitive impairment, and pregnant persons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Sensory Testing (QST): Specifically including Conditioned Pain Modulation (CPM) and Temporal Summation (TS) protocols. | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). | CPM measures the efficiency of the body's pain-inhibiting pathways. A higher positive value indicates a more effective pain modulation system (better outcome). TS measures pain sensitization. A higher score indicates greater central sensitization to pain (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale (PCS) | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). | The scale score ranges from 0 to 52. A higher score indicates a greater level of pain catastrophizing (a worse outcome). |
| Oswestry Disability Index (ODI) | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). | This index measures disability due to low back pain, with the score reported as a percentage from 0% to 100%. A score of 0% indicates no disability, while 100% indicates the most severe disability (a worse outcome). |
| Tampa Scale for Kinesiophobia-13 (TSK-13) | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). | The scale scores range from 13 to 52. A higher score indicates a greater degree of kinesiophobia (fear of movement), which is a worse outcome. |
| Visual Analog Scale (VAS) | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). | This scale measures the intensity of pain. It is typically a 100-millimeter line on which participants mark their pain level. A score of 0 mm indicates no pain, while 100 mm indicates the worst pain imaginable. A lower score represents a better outcome. |
| Lumbar Range of Motion (ROM) | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). | This is a physical measurement of lumbar spine flexibility, objectively assessed using a dual inclinometer. The range of motion for flexion, lateral bending is reported in degrees (°). A higher value, representing a greater range of movement, indicates better physical function (a better outcome). |
| Fear-Avoidance Beliefs Questionnaire (FABQ) | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). | This questionnaire has two subscales: Physical Activity (range 0-24) and Work (range 0-42). For both scales, a higher score indicates stronger fear-avoidance beliefs (a worse outcome). |
Countries
South Korea
Outcome results
None listed