Virtual RealityNCT07207083
Can Virtual Reality Exercise Help Restore Both Body and Mind in Chronic Low Back Pain
A study testing Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s) and Conventional Exercise Program (Matched Exercise, without VR) in people with Virtual Reality and Kinesiophobia, run by dongmin kang at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Virtual Reality, Kinesiophobia, Chronic Low Back Pain (CLBP)
- What is being tested?
- Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s) and Conventional Exercise Program (Matched Exercise, without VR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Immersive Virtual Reality-based Exercise on Somatosensory Function, Pain, and Psychological and Functional Recovery in Patients With Chronic Low Back Pain
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
Read more
- 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
- Being tested
- Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s), Conventional Exercise Program (Matched Exercise, without VR)
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s)Behavioural
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.
Conventional Exercise Program (Matched Exercise, without VR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR Exercise Group | Experimental | Participants perform a 15-minute exercise program using immersive virtual reality (FitXR app with Meta Quest 3s). Receives: 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. Receives: Behavioral: Conventional Exercise Program (Matched Exercise, without VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Secondary outcomes (6)
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: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Pain Catastrophizing Scale (PCS)
The scale score ranges from 0 to 52. A higher score indicates a greater level of pain catastrophizing (a worse outcome).
Measured: 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: 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: 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: 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: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start28 Sep 2025
- Primary completion16 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dongmin kang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dongmin kang, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207083
- Sponsor's protocol ID
- SYU 2025-08-019-002
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immersive Virtual Reality-based Exercise on Somatosensory Function, Pain, and Psychological and Functional Recovery in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07207083
- Acronym / sponsor ID
- SYU 2025-08-019-002
- Conditions
- Virtual Reality, Kinesiophobia, Chronic Low Back Pain (CLBP), Central Sensitization, Fear of Movement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- dongmin kangUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Exercise Group | Experimental | Behavioral: Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s)Participants perform a 15-minute exercise program using immersive virtual reality (FitXR app with Meta Quest 3s). |
| Non-VR Exercise Group | Active comparator | Behavioral: Conventional Exercise Program (Matched Exercise, without VR)Participants perform the same 15-minute exercise program, but without VR equipment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | VR Exercise Group |
| 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. | Behavioural | Non-VR Exercise Group |
Primary outcome
Quantitative Sensory Testing (QST): Specifically including Conditioned Pain Modulation (CPM) and Temporal Summation (TS) protocols.
Time frame: 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).
6 secondary outcomes
Tampa Scale for Kinesiophobia-13 (TSK-13)
Time frame: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Pain Catastrophizing Scale (PCS)
Time frame: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Oswestry Disability Index (ODI)
Time frame: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Visual Analog Scale (VAS)
Time frame: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Lumbar Range of Motion (ROM)
Time frame: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality-based Exercise (FitXR, Meta Quest 3s) and Conventional Exercise Program (Matched Exercise, without VR) in people with Virtual Reality and Kinesiophobia, run by dongmin kang at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Sensory Testing (QST): Specifically including Conditioned Pain Modulation (CPM) and Temporal Summation (TS) protocols. (time frame: Measured at Week 1 (baseline), Week 6 (post-intervention), and Week 8 (follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.