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

NCT ID: NCT07172828

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2026-12-25

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality-Based Rehabilitation Group

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).

Group Type: EXPERIMENTAL

Virtual Reality-Based Rehabilitation

Intervention Type: 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 Rehabilitation Group

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).

Group Type: ACTIVE_COMPARATOR

Conventional Motor Control Exercises

Intervention Type: 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).

Interventions

Virtual Reality-Based 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).

Intervention Type: BEHAVIORAL

Conventional Motor Control Exercises

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

VR-Based Exercise; VR Rehabilitation; Progressive Stabilization Exercises; Standard Exercise Therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

ABDURAHİM ASLIYÜCE

Principal Investigator, Physiotherapist (MSc), Research Assistant, PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Özlem Ülger, PT, PhD

Role: STUDY_DIRECTOR

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Abdurahim Aslıyüce, Research Assistant, MSc, PT

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Abdurahim Aslıyüce, MSc, PT

Role: CONTACT

abdurahimasliyuce@hacettepe.edu.tr

+905422476991

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 38407948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34831562 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29573870 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22231424 (View on PubMed)

Other Identifiers

FTREK25/40

Identifier Type: -

Identifier Source: org_study_id