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NCT Number: NCT07172828

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

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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Key information

Conditions

Chronic Low Back Pain (CLBP) Back Pain Exercise Therapy Low Back Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Postural Balance Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality-Based Rehabilitation

Behavioral

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).

Other names: VR-Based Exercise, VR Rehabilitation

Conventional Motor Control Exercises

Behavioral

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).

Other names: Progressive Stabilization Exercises, Standard Exercise Therapy

Primary outcomes

  1. Change in Transversus Abdominis Thickness (mm)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Measured by ultrasound in supine hook-lying position.

  2. Change in Internal Oblique Thickness (mm)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Measured by ultrasound in supine hook-lying position

  3. Change in External Oblique Thickness (mm)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Measured by ultrasound in supine hook-lying position

  4. Change in Rectus Abdominis Thickness (mm)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Measured by ultrasound in supine hook-lying position

  5. Change in Thoracolumbar Fascia Thickness (mm)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Measured bilaterally at L3 level in prone position.

  6. Change in Thoracolumbar Fascia Morphology (categorical)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

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

  7. Change in Postural Sway (mm)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

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

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

    Time frame: 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

  1. Pain Intensity

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

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

  2. Functional Disability

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Functional status assessed with the Oswestry Disability Index

  3. Functional Disability

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Functional status assessed with the Back Performance Scale.

  4. Lumbar Paravertebral Muscle Stiffness (N/m)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Assessed with MyotonPRO at bilateral L5.

  5. Lumbar Paravertebral Muscle Elasticity (ratio)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

    Assessed with MyotonPRO at bilateral L5.

  6. Trunk Muscle Endurance (mmHg, seconds)

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

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

  7. Fear-Avoidance Beliefs

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

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

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

    Time frame: 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.

  9. Patient Satisfaction

    Time frame: 8 weeks, 3 months, 6 months.

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

  10. Exercise Adherence

    Time frame: During the 8-week intervention.

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

  11. Body Composition

    Time frame: Baseline, 8 weeks, 3 months, 6 months.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Abdurahim Aslıyüce, MSc, PT

CONTACT

[email protected]

+905422476991

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Acronym: VR-LBPREHAB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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