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

NCT ID: NCT07207083

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-28
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR Exercise Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Non-VR Exercise Group

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

Group Type: ACTIVE_COMPARATOR

Conventional Exercise Program (Matched Exercise, without VR)

Intervention Type: 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.

Interventions

Immersive 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.

Intervention Type: BEHAVIORAL

Conventional 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

dongmin kang

OTHER

Sponsor Role: lead

Responsible Party

dongmin kang

Master's Degree Candidate

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sahmyook University, Science Hall 3

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

SYU 2025-08-019-002

Identifier Type: -

Identifier Source: org_study_id