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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHacettepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Malignancy.

Pregnancy.

History of epilepsy (including photosensitive seizures), dementia, migraine, or other neurological disorders limiting VR use.

Surgery within the past 6 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Virtual Reality-Based Rehabilitation GroupExperimental treatment 1 intervention
Group B: Conventional Rehabilitation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Transversus Abdominis Thickness (mm)

Measured by ultrasound in supine hook-lying position.

Time frame
Baseline, 8 weeks, 3 months, 6 months.
2

Change in Internal Oblique Thickness (mm)

Measured by ultrasound in supine hook-lying position

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

Change in External Oblique Thickness (mm)

Measured by ultrasound in supine hook-lying position

Time frame
Baseline, 8 weeks, 3 months, 6 months.
4

Change in Rectus Abdominis Thickness (mm)

Measured by ultrasound in supine hook-lying position

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

Secondary outcomes

1

Pain Intensity

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

Time frame
Baseline, 8 weeks, 3 months, 6 months.
2

Functional Disability

Functional status assessed with the Oswestry Disability Index

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

Functional Disability

Functional status assessed with the Back Performance Scale.

Time frame
Baseline, 8 weeks, 3 months, 6 months.
4

Lumbar Paravertebral Muscle Stiffness (N/m)

Assessed with MyotonPRO at bilateral L5.

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

Other outcomes

Sponsors and contacts

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