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

NCT07172828 | Not Yet Recruiting

• 1 other identifier: FTREK25/40
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low Back Pain (CLBP); Musculoskeletal Pain; Postural Balance; Exercise Therapy

Keywords

Low Back Pain; Virtual Reality Rehabilitation; Muscle Architecture; Thoracolumbar Fascia; Balance Control; Exercise Therapy

Outcome Measures

Primary Outcomes (8)

• Change in Transversus Abdominis Thickness (mm)

  Measured by ultrasound in supine hook-lying position.

  Baseline, 8 weeks, 3 months, 6 months.

• Change in Internal Oblique Thickness (mm)

  Measured by ultrasound in supine hook-lying position

  Baseline, 8 weeks, 3 months, 6 months.

• Change in External Oblique Thickness (mm)

  Measured by ultrasound in supine hook-lying position

  Baseline, 8 weeks, 3 months, 6 months.

• Change in Rectus Abdominis Thickness (mm)

  Measured by ultrasound in supine hook-lying position

  Baseline, 8 weeks, 3 months, 6 months.

• Change in Thoracolumbar Fascia Thickness (mm)

  Measured bilaterally at L3 level in prone position.

  Baseline, 8 weeks, 3 months, 6 months.

• Change in Thoracolumbar Fascia Morphology (categorical)

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

  Baseline, 8 weeks, 3 months, 6 months.

• Change in Postural Sway (mm)

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

  Baseline, 8 weeks, 3 months, 6 months.

• Change in Limits of Stability (mm/°/s)

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

  Baseline, 8 weeks, 3 months, 6 months.

Secondary Outcomes (11)

• Pain Intensity

  Baseline, 8 weeks, 3 months, 6 months.

• Functional Disability

  Baseline, 8 weeks, 3 months, 6 months.

• Functional Disability

  Baseline, 8 weeks, 3 months, 6 months.

• Lumbar Paravertebral Muscle Stiffness (N/m)

  Baseline, 8 weeks, 3 months, 6 months.

• Lumbar Paravertebral Muscle Elasticity (ratio)

  Baseline, 8 weeks, 3 months, 6 months.

Study Arms (2)

Virtual Reality-Based Rehabilitation Group

EXPERIMENTAL

Participants 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).

Behavioral: Virtual Reality-Based Rehabilitation

Conventional Rehabilitation Group

ACTIVE COMPARATOR

Participants 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).

Behavioral: Conventional Motor Control Exercises

Interventions

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).

Also known as: VR-Based Exercise, VR Rehabilitation

Virtual Reality-Based Rehabilitation Group

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).

Also known as: Progressive Stabilization Exercises, Standard Exercise Therapy

Conventional Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06200, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Özlem Ülger, PT, PhD

  Hacettepe University, Faculty of Physical Therapy and Rehabilitation

  STUDY DIRECTOR

• Abdurahim Aslıyüce, Research Assistant, MSc, PT

  Hacettepe University, Faculty of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdurahim Aslıyüce, MSc, PT

CONTACT

+905422476991; abdurahimasliyuce@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized into two groups using a sealed-envelope method: a virtual reality group and a conventional rehabilitation group. The VR group will perform 20 minutes of motor control exercises plus 20 minutes of Pilates-based VR games (5 reps/set), while the control group will complete 40 minutes of progressive motor control/stabilization exercises (10 reps/set). Both groups will train 3 times per week for 8 weeks. Ultrasound imaging assessments will be performed by an experienced physiotherapist who will remain blinded to group allocation. This ensures that outcome assessment of muscle architecture is conducted under blinded conditions. Participants and care providers will not be blinded due to the visible nature of the interventions. Evaluations at baseline, 8 weeks, 3 and 6 months will include ultrasound, balance, pain, disability, and patient satisfaction.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physiotherapist (MSc), Research Assistant, PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 15, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)