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

NCT07172828 — Not applicable, Not yet recruiting, 48 participants, Hacettepe University

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

RegistryNCT07172828, acronym VR-LBPREHAB
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment48 (Estimated)
SponsorHacettepe University (Other)
ConditionsChronic Low Back Pain (CLBP), Musculoskeletal Pain, Postural Balance, Exercise Therapy
InterventionsVirtual Reality-Based Rehabilitation, Conventional Motor Control Exercises (Behavioral)
Datesstart 2025-10-13 (estimated), primary completion 2026-10-13 (estimated), completion 2026-12-25 (estimated), first posted 2025-09-15, last updated 2025-09-15
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Low Back Pain (CLBP) All trials for Musculoskeletal Pain All trials of Virtual Reality-Based Rehabilitation All trials of Conventional Motor Control Exercises

-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. 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.

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Virtual Reality-Based Rehabilitation GroupExperimentalBehavioral: Virtual Reality-Based RehabilitationParticipants 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).
Conventional Rehabilitation GroupActive comparatorBehavioral: Conventional Motor Control ExercisesParticipants 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).
  • Virtual Reality-Based Rehabilitation (Behavioral), also known as 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 Exercises (Behavioral), also known as 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).

+Outcome measures

Primary outcomes

  • Change in Transversus Abdominis Thickness (mm) [Baseline, 8 weeks, 3 months, 6 months.]: Measured by ultrasound in supine hook-lying position.
  • Change in Internal Oblique Thickness (mm) [Baseline, 8 weeks, 3 months, 6 months.]: Measured by ultrasound in supine hook-lying position
  • Change in External Oblique Thickness (mm) [Baseline, 8 weeks, 3 months, 6 months.]: Measured by ultrasound in supine hook-lying position
  • Change in Rectus Abdominis Thickness (mm) [Baseline, 8 weeks, 3 months, 6 months.]: Measured by ultrasound in supine hook-lying position
  • Change in Thoracolumbar Fascia Thickness (mm) [Baseline, 8 weeks, 3 months, 6 months.]: Measured bilaterally at L3 level in prone position.
  • Change in Thoracolumbar Fascia Morphology (categorical) [Baseline, 8 weeks, 3 months, 6 months.]: ssessed bilaterally at L3 level in prone position (regular vs. irregular morphology).
  • Change in Postural Sway (mm) [Baseline, 8 weeks, 3 months, 6 months.]: Anterior-posterior and medio-lateral sway measured by force platform (Freemed, Sensor Medica).
  • Change in Limits of Stability (mm/°/s) [Baseline, 8 weeks, 3 months, 6 months.]: Maximum excursion, reaction time, movement velocity, and directional control measured by force platform (Freemed, Sensor Medica).

Secondary outcomes

  • Pain Intensity [Baseline, 8 weeks, 3 months, 6 months.]: Pain severity measured using the Numeric Pain Rating Scale (0-10).
  • Functional Disability [Baseline, 8 weeks, 3 months, 6 months.]: Functional status assessed with the Oswestry Disability Index
  • Functional Disability [Baseline, 8 weeks, 3 months, 6 months.]: Functional status assessed with the Back Performance Scale.
  • Lumbar Paravertebral Muscle Stiffness (N/m) [Baseline, 8 weeks, 3 months, 6 months.]: Assessed with MyotonPRO at bilateral L5.
  • Lumbar Paravertebral Muscle Elasticity (ratio) [Baseline, 8 weeks, 3 months, 6 months.]: Assessed with MyotonPRO at bilateral L5.
  • Trunk Muscle Endurance (mmHg, seconds) [Baseline, 8 weeks, 3 months, 6 months.]: Endurance of the Transversus Abdominis muscle assessed with the Stabilizer Pressure Biofeedback device.
  • Fear-Avoidance Beliefs [Baseline, 8 weeks, 3 months, 6 months.]: Psychological aspects evaluated using the Fear-Avoidance Beliefs Questionnaire (FABQ).
  • Change in Quality of Life (Nottingham Health Profile Total Score) [Baseline, 8 weeks, 3 months, 6 months.]: 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.
  • Patient Satisfaction [8 weeks, 3 months, 6 months.]: Satisfaction levels assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0).
  • Exercise Adherence [During the 8-week intervention.]: Recorded via exercise diary including weekly frequency and duration of sessions.
  • Body Composition [Baseline, 8 weeks, 3 months, 6 months.]: Body weight, BMI, and body fat percentage measured using a bioimpedance analyzer (Tanita MC180MA).

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

FacilityCityCountryStatus
Hacettepe UniversityAnkaraTurkey (Türkiye)

+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. PMID 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. PMID 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. PMID 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. PMID 22231424

+Investigators

  • Özlem Ülger, PT, PhD, Study director, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
  • Abdurahim Aslıyüce, Research Assistant, MSc, PT, Principal investigator, Hacettepe University, Faculty of Physical Therapy and Rehabilitation