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Chronic Low Back Pain (CLBP)VR-LBPREHABNCT07172828

Virtual Reality-Based Rehabilitation in Chronic Low Back Pain: Effects on Muscle Architecture, Balance, and Satisfaction (VR-LBPREHAB)

A study testing Virtual Reality-Based Rehabilitation in people with Chronic Low Back Pain (CLBP) and Musculoskeletal Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Chronic low back pain is a common musculoskeletal disorder that causes pain, disability, and reduced quality of life. It is often related to changes in trunk muscle function, thoracolumbar fascia morphology, and impaired balance control. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Virtual Reality-Based Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 Oct 2025to 25 Dec 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years.
  • Chronic low back pain persisting for ≥ 3 months.
  • Literacy and Montreal Cognitive Assessment (MoCA) score > 21.
  • Voluntary participation with signed informed consent.

Who cannot join

  • Malignancy.
  • Pregnancy.
  • History of epilepsy (including photosensitive seizures), dementia, migraine, or other neurological disorders limiting VR use.
  • Surgery within the past 6 months.
  • Received physiotherapy or rehabilitation services in the past 6 months.
  • Presence of acute infection.
  • Unhealed fracture.
  • Withdrawal of informed consent at any stage of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abdurahim Aslıyüce, MSc, PT contact

+905422476991

abdurahimasliyuce@hacettepe.edu.tr

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara, 06200

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Virtual Reality-Based Rehabilitation on Muscle Architecture, Balance Control, and Patient Satisfaction in Individuals With Chronic Low Back Pain

Chronic low back pain is a common musculoskeletal disorder that causes pain, disability, and reduced quality of life. It is often related to changes in trunk muscle function, thoracolumbar fascia morphology, and impaired balance control. Although conventional motor control exercises are effective, patient motivation and adherence can be limited. Virtual reality (VR)-based rehabilitation offers interactive and engaging environments that may improve compliance and provide additional therapeutic benefits.

This study is a randomized controlled trial designed to investigate the effects of VR-based rehabilitation compared with conventional motor control exercises in individuals with chronic low back pain. A total of 40-50 participants aged 18-65 will be recruited and randomly assigned to one of two groups: (1) VR-based rehabilitation or (2) conventional exercise therapy. Both programs will last 8 weeks, delivered three times per week for 40 minutes per session.

Read more

The primary outcomes include muscle architecture assessed by ultrasound imaging, thoracolumbar fascia morphology, and postural balance control measured by force platform tests. Secondary outcomes include pain intensity, disability, fear-avoidance beliefs, quality of life, and patient satisfaction.

The findings of this study are expected to provide new insights into the role of VR in rehabilitation and contribute to evidence-based strategies for managing chronic low back pain. By exploring the effects on both physical and patient-reported outcomes, the study may highlight innovative approaches to improve adherence, reduce pain, and enhance daily function in affected individuals.

Read the detailed description

Chronic low back pain is a prevalent musculoskeletal condition associated with altered muscle activation, impaired postural control, and thoracolumbar fascia changes that may contribute to persistent pain and disability. Conventional rehabilitation approaches such as stabilization and motor control exercises are widely recommended, yet patient adherence and motivation often limit their effectiveness.

Virtual reality (VR)-based rehabilitation integrates visual, auditory, and interactive elements that can enhance engagement, provide distraction from pain, and encourage more consistent exercise participation. While VR interventions have shown benefits in populations such as stroke, cerebral palsy, and multiple sclerosis, the evidence in chronic low back pain remains limited.

This randomized controlled trial is designed to investigate the clinical and functional effects of VR-based rehabilitation compared with conventional motor control exercises in individuals with chronic low back pain. The intervention will combine traditional physiotherapy approaches with VR-based exercises to evaluate potential improvements in muscle architecture, balance control, and patient-centered outcomes such as satisfaction and adherence.

The study will contribute novel data on the feasibility and effectiveness of VR-based rehabilitation in chronic low back pain, with the goal of providing physiotherapists and clinicians with evidence to guide innovative treatment strategies. The adapted approach is expected to promote adherence, improve functional outcomes, and address gaps in the current literature on VR applications in musculoskeletal rehabilitation.

Being tested
Virtual Reality-Based Rehabilitation, Conventional Motor Control Exercises
Keywords
Low Back Pain, Virtual Reality Rehabilitation, Muscle Architecture, Thoracolumbar Fascia, Balance Control, Exercise Therapy
Medical subject headings
Musculoskeletal Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality-Based RehabilitationBehavioural

    Also called VR-Based Exercise, VR Rehabilitation

    Participants receive 20 minutes of motor control exercises combined with 20 minutes of Pilates-inspired virtual reality games (5 repetitions per set). Training will be delivered three times per week, 40 minutes per session, for 8 weeks (24 sessions in total).

  • Conventional Motor Control ExercisesBehavioural

    Also called Progressive Stabilization Exercises, Standard Exercise Therapy

    Participants perform 40 minutes of progressive spinal stabilization and motor control exercises (10 repetitions per set), three times per week for 8 weeks (24 sessions in total).

Study groups in NCT07172828
Study groupRoleWhat they receive
Virtual Reality-Based Rehabilitation GroupExperimentalParticipants receive 20 minutes of motor control exercises combined with 20 minutes of Pilates-based virtual reality games (5 repetitions per set), delivered three times per week for 8 weeks (24 sessions in total).
Receives: Behavioral: Virtual Reality-Based Rehabilitation
Conventional Rehabilitation GroupActive comparatorParticipants perform 40 minutes of progressive spinal stabilization and motor control exercises (10 repetitions per set), delivered three times per week for 8 weeks (24 sessions in total).
Receives: Behavioral: Conventional Motor Control Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Transversus Abdominis Thickness (mm)

    Measured by ultrasound in supine hook-lying position.

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  2. Change in Internal Oblique Thickness (mm)

    Measured by ultrasound in supine hook-lying position

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  3. Change in External Oblique Thickness (mm)

    Measured by ultrasound in supine hook-lying position

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  4. Change in Rectus Abdominis Thickness (mm)

    Measured by ultrasound in supine hook-lying position

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  5. Change in Thoracolumbar Fascia Thickness (mm)

    Measured bilaterally at L3 level in prone position.

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  6. Change in Thoracolumbar Fascia Morphology (categorical)

    ssessed bilaterally at L3 level in prone position (regular vs. irregular morphology).

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  7. Change in Postural Sway (mm)

    Anterior-posterior and medio-lateral sway measured by force platform (Freemed, Sensor Medica).

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  8. Change in Limits of Stability (mm/°/s)

    Maximum excursion, reaction time, movement velocity, and directional control measured by force platform (Freemed, Sensor Medica).

    Measured: Baseline, 8 weeks, 3 months, 6 months.

Secondary outcomes (11)
  1. Pain Intensity

    Pain severity measured using the Numeric Pain Rating Scale (0-10).

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  2. Functional Disability

    Functional status assessed with the Oswestry Disability Index

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  3. Functional Disability

    Functional status assessed with the Back Performance Scale.

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  4. Lumbar Paravertebral Muscle Stiffness (N/m)

    Assessed with MyotonPRO at bilateral L5.

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  5. Lumbar Paravertebral Muscle Elasticity (ratio)

    Assessed with MyotonPRO at bilateral L5.

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  6. Trunk Muscle Endurance (mmHg, seconds)

    Endurance of the Transversus Abdominis muscle assessed with the Stabilizer Pressure Biofeedback device.

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  7. Fear-Avoidance Beliefs

    Psychological aspects evaluated using the Fear-Avoidance Beliefs Questionnaire (FABQ).

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  8. Change in Quality of Life (Nottingham Health Profile Total Score)

    Quality of life assessed using the Nottingham Health Profile (NHP); includes domains of pain, emotional reaction, sleep, social isolation, physical activity, and energy. Higher scores indicate poorer quality of life.

    Measured: Baseline, 8 weeks, 3 months, 6 months.

  9. Patient Satisfaction

    Satisfaction levels assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0).

    Measured: 8 weeks, 3 months, 6 months.

  10. Exercise Adherence

    Recorded via exercise diary including weekly frequency and duration of sessions.

    Measured: During the 8-week intervention.

  11. Body Composition

    Body weight, BMI, and body fat percentage measured using a bioimpedance analyzer (Tanita MC180MA).

    Measured: Baseline, 8 weeks, 3 months, 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start13 Oct 2025 (estimated)
  3. Primary completion13 Oct 2026 (estimated)
  4. Study completion25 Dec 2026 (estimated)

Resources

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
This study is designed as a two-arm randomized controlled trial with parallel assignment. A total of 40-50 participants with chronic low back pain will be randomly allocated to one of two groups: (1) the experimental group, receiving an 8-week virtual reality (VR)-based rehabilitation program, or (2) the control group, receiving conventional motor control exercises. Each program will be delivered three times per week, 40 minutes per session, for a total of 24 sessions. The parallel assignment model ensures that each participant receives only one type of intervention throughout the study period, allowing for a direct comparison between VR-based rehabilitation and conventional exercise therapy.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07172828
Sponsor's protocol ID
FTREK25/40
Acronym
VR-LBPREHAB
Status last verified
Sep 2025
First submitted
26 Aug 2025
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because of privacy and confidentiality considerations. All data will remain anonymized and securely stored, with access restricted to the research team in accordance with ethics committee approval.

Publications

  • Taguchi T, Tesarz J, Mense S. The thoracolumbar fascia as a source of low back pain. In: Fascia Research II - Basic Science and Implications for Conventional and Complementary Healthcare. Munich: Elsevier GmbH; 2009:251.

  • Li R, Li Y, Kong Y, Li H, Hu D, Fu C, Wei Q. Virtual Reality-Based Training in Chronic Low Back Pain: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2024 Feb 26;26:e45406. doi: 10.2196/45406.

    PubMed 38407948
  • Brea-Gomez B, Torres-Sanchez I, Ortiz-Rubio A, Calvache-Mateo A, Cabrera-Martos I, Lopez-Lopez L, Valenza MC. Virtual Reality in the Treatment of Adults with Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Int J Environ Res Public Health. 2021 Nov 11;18(22):11806. doi: 10.3390/ijerph182211806.

    PubMed 34831562
  • Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

    PubMed 29573870
  • Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

    PubMed 22231424

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality-Based Rehabilitation in people with Chronic Low Back Pain (CLBP) and Musculoskeletal Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).

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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 15 Sep 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 Turkey (Türkiye). 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?

Contact Abdurahim Aslıyüce, MSc, PT (+905422476991, abdurahimasliyuce@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Transversus Abdominis Thickness (mm) (time frame: Baseline, 8 weeks, 3 months, 6 months.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07172828, which also lists 5 linked publications.

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 15 Sep 2025.

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