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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Exercise Group | Experimental | Participants perform a 15-minute exercise program using immersive virtual reality (FitXR app with Meta Quest 3s). |
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| Non-VR Exercise Group | Active Comparator | Participants perform the same 15-minute exercise program, but without VR equipment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Sensory Testing (QST): Specifically including Conditioned Pain Modulation (CPM) and Temporal Summation (TS) protocols. | 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). | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). |
| Measure | Description | Time Frame |
|---|---|---|
| Tampa Scale for Kinesiophobia-13 (TSK-13) | 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. | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). |
| Pain Catastrophizing Scale (PCS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahmyook University, Science Hall 3 | Seoul | Seoul | 01795 | South Korea |
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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.
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| Conventional Exercise Program (Matched Exercise, without VR) | Behavioral | 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. |
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The scale score ranges from 0 to 52. A higher score indicates a greater level of pain catastrophizing (a worse outcome). |
| Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). |
| Oswestry Disability Index (ODI) | 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). | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). |
| Fear-Avoidance Beliefs Questionnaire (FABQ) | 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). | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). |
| Visual Analog Scale (VAS) | 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. | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). |
| Lumbar Range of Motion (ROM) | 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). | Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up). |
| ID | Term |
|---|---|
| D000092442 | Kinesiophobia |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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