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

NCT07207083 | Enrolling By Invitation

• 1 other identifier: SYU 2025-08-019-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (6)

• Tampa Scale for Kinesiophobia-13 (TSK-13)

  Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).

• Pain Catastrophizing Scale (PCS)

  Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).

• Oswestry Disability Index (ODI)

  Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).

• Fear-Avoidance Beliefs Questionnaire (FABQ)

  Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).

• Visual Analog Scale (VAS)

  Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).

Study Arms (2)

VR Exercise Group

EXPERIMENTAL

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

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

Non-VR Exercise Group

ACTIVE COMPARATOR

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

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

Interventions

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.

VR Exercise Group

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.

Non-VR Exercise Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• dongmin kang: lead

Study Sites (1)

Sahmyook University, Science Hall 3

Seoul, Seoul, 01795, South Korea

Location

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's Degree Candidate

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: September 28, 2025
• Primary Completion: December 16, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

KR (1)