Can Virtual Reality Exercise Help Restore Both Body and Mind in Chronic Low Back Pain

dongmin kang

Status: Invitation-only

Conditions: Kinesiophobia; Chronic Low Back Pain (CLBP); Central Sensitization; Fear of Movement; Virtual Reality

Treatments: Behavioral: Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s); Behavioral: Conventional Exercise Program (Matched Exercise, without VR)

Study type: Interventional

Funder types: Other

Identifiers

NCT07207083

SYU 2025-08-019-002

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

VR Exercise Group

Experimental group

Description:

Participants perform a 15-minute exercise program using immersive virtual reality (FitXR app with Meta Quest 3s).

Treatment:

Behavioral: Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s)

Non-VR Exercise Group

Active Comparator group

Description:

Participants perform the same 15-minute exercise program, but without VR equipment.

Treatment:

Behavioral: Conventional Exercise Program (Matched Exercise, without VR)