Virtual Reality-Based Rehabilitation Versus Conventional Therapy in Patients With Chronic Low Back Pain

NCT07463105 | Recruiting

• 1 other identifier: VR-LBP-RCT-2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of rehabilitation using virtual reality compared with conventional physiotherapy in patients with chronic low back pain. The study will be conducted as a prospective, randomized controlled trial including 80 patients aged 40-65 years diagnosed with chronic low back pain lasting at least three months. Participants will be randomly assigned to two groups: an experimental group receiving conventional rehabilitation supplemented with non-immersive virtual reality training using the Tecnobody Homing Studio system, and a control group receiving conventional rehabilitation alone. Both groups will participate in a four-week rehabilitation program. The virtual reality training will replace a portion of conventional exercises and will focus on improving movement quality, postural control, coordination, and functional mobility through interactive tasks with visual and auditory biofeedback. The system utilizes a 3D camera enabling markerless motion analysis and real-time visual feedback to support movement correction and identification of functional deficits. Outcome measures will include assessments of balance, posture, joint mobility, lower limb strength and endurance, pain intensity, pressure pain threshold, kinesiophobia, perceived stress, anxiety and depression, functional disability, quality of life, and motivation for physical activity. Measurements will be conducted at baseline, immediately after completion of the four-week rehabilitation program, and at an eight-week follow-up. The results of this study are expected to provide clinical evidence regarding the effectiveness of virtual reality-assisted rehabilitation in patients with chronic low back pain and may contribute to the development of evidence-based rehabilitation strategies incorporating digital technologies.

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back Pain; Virtual Reality Rehabilitation; Kinesiophobia; Postural Control

Outcome Measures

Primary Outcomes (10)

• Postural stability measured using center of pressure path length

  Assessment of postural stability using a stabilometric platform (TecnoBody Homing system) during standardized quiet standing tasks. The center of pressure (COP) path length will be measured as an indicator of postural sway. Higher values indicate greater postural instability.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Pressure pain threshold measured using digital algometry

  Assessment of pressure pain threshold using a digital algometer applied to standardized anatomical points in the lumbar region. The pressure pain threshold represents the minimum pressure (kg/cm²) that induces pain perception. Higher values indicate greater tolerance to pressure and lower pain sensitivity.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Lower limb functional performance measured using the Sit-to-Stand test

  Assessment of lower limb strength and functional performance using the Sit-to-Stand test. The number of repetitions completed within a standardized time period or the time required to perform repeated sit-to-stand movements will be recorded. Higher performance indicates better functional capacity of the lower limbs.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Lumbar spine mobility measured using the Modified Schober Test

  Assessment of lumbar spine mobility using the Modified Schober Test. The change in distance (cm) during trunk flexion will be recorded. Higher values indicate greater lumbar spine mobility.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Postural stability measured using center of pressure sway area

  Assessment of postural stability using a stabilometric platform (TecnoBody Homing system). The sway area of the center of pressure (COP) will be measured as an indicator of postural control. Higher values indicate greater postural instability.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Trunk posture and movement analysis measured using video motion analysis

  Assessment of trunk posture and postural alignment using video motion analysis performed with the software Kinovea. Angular and linear parameters of body alignment will be measured from standardized photographs and video recordings.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Hip joint range of motion measured using digital goniometry

  Assessment of hip joint mobility using digital goniometry. Range of motion will be measured in degrees (°). Higher values indicate greater hip joint mobility.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Ankle joint range of motion measured using digital goniometry

  Assessment of ankle joint mobility using digital goniometry. Range of motion will be measured in degrees (°). Higher values indicate greater ankle joint mobility.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Body fat percentage measured using bioelectrical impedance analysis

  Assessment of body fat percentage using bioelectrical impedance analysis performed with a Tanita body composition analyzer. Higher values indicate greater body fat percentage.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Skeletal muscle mass measured using bioelectrical impedance analysis

  Assessment of skeletal muscle mass using bioelectrical impedance analysis performed with a Tanita body composition analyzer. Higher values indicate greater skeletal muscle mass.

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

Secondary Outcomes (11)

• Functional disability measured using the Oswestry Disability Index (ODI)

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Pain intensity measured using the Numeric Rating Scale (NRS)

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Functional disability measured using the Roland-Morris Disability Questionnaire (RMDQ)

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Kinesiophobia measured using the Tampa Scale of Kinesiophobia (TSK-11)

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

• Quality of life measured using the WHOQOL-BREF questionnaire

  Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).

Study Arms (2)

Virtual Reality-Assisted Rehabilitation

EXPERIMENTAL

Participants in the experimental group will undergo a conventional rehabilitation program supplemented with non-immersive virtual reality training using the Tecnobody Homing Studio system. The virtual reality exercises will replace a portion of conventional exercises and will focus on improving movement quality, postural control, coordination, and functional mobility through interactive tasks with visual and auditory biofeedback. The rehabilitation program will last four weeks.

Other: Virtual Reality-Assisted Rehabilitation

Conventional Rehabilitation

ACTIVE COMPARATOR

Participants in the control group will receive a standard conventional rehabilitation program consisting of therapeutic exercises aimed at improving spinal mobility, core stability, balance, coordination, and functional movement patterns. The rehabilitation program will last four weeks.

Other: Conventional Rehabilitation

Interventions

Virtual Reality-Assisted Rehabilitation OTHER

Non-immersive virtual reality training using the Tecnobody Homing Studio system. The intervention consists of interactive therapeutic exercises aimed at improving postural control, coordination, movement quality, and functional mobility through task-oriented activities with visual and auditory biofeedback. The system uses a three-dimensional camera for markerless motion analysis and real-time movement feedback. The virtual reality exercises replace a portion of conventional rehabilitation exercises during a four-week rehabilitation program.

Virtual Reality-Assisted Rehabilitation

Conventional Rehabilitation OTHER

Standard physiotherapy program consisting of therapeutic exercises aimed at improving spinal mobility, core stability, balance, coordination, and lower limb functional performance. The rehabilitation program includes task-oriented exercises and postural control training performed under the supervision of a physiotherapist during a four-week intervention period.

Conventional Rehabilitation

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic low back pain lasting at least 3 months
• Average pain intensity ≥4/10 during the previous week on the Numeric Rating Scale (NRS)
• Age between 40 and 65 years
• Ability to walk independently without assistive devices
• Functional disability related to low back pain defined as Oswestry Disability Index (ODI) ≥15%
• No contraindications to participation in a physiotherapy program or virtual reality training
• Ability to understand study procedures and follow instructions
• Written informed consent to participate in the study

You may not qualify if:

• Acute low back pain or pain lasting less than 3 months
• Neurological, orthopedic, rheumatological, oncological diseases or active inflammatory conditions that may affect study outcomes
• Cognitive impairment limiting the ability to understand instructions or participate in rehabilitation
• Contraindications to virtual reality training such as severe dizziness, nausea, epilepsy, or severe visual or auditory impairment
• Contraindications to body composition analysis (e.g., implanted cardiac pacemaker or other electronic implants)
• Unstable medical condition or uncontrolled cardiovascular or respiratory disorders preventing participation in rehabilitation
• Participation in other rehabilitation programs during the study period
• Failure to complete the four-week rehabilitation program
• Lack of written informed consent

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

Sensoreh Pastyrzak Centrum rehabilitacji niemowląt, dzieci i dorosłych

Sanok, Podkarpackie Voivodeship, 38-500, Poland

RECRUITING

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Michal Pastyrzak

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

• Agnieszka Guzik

  University of Rzeszow

  STUDY CHAIR

Central Study Contacts

Michal Pastyrzak

CONTACT

+48 664221066; michalpastyrzak@gmail.com

Agnieszka Guzik

CONTACT

+48 17 851 8965; aguzik@ur.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed about the specific group allocation or study hypothesis and will be unaware of the specific intervention allocation. Outcome assessors performing the measurements will be blinded to group assignment. Due to the nature of the rehabilitation intervention, therapists delivering the treatment cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two parallel groups. The experimental group will receive conventional rehabilitation supplemented with non-immersive virtual reality training using the Tecnobody Homing Studio system, while the control group will receive conventional rehabilitation alone. The rehabilitation program will last four weeks in both groups. Outcome assessments will be performed at baseline, immediately after completion of the intervention, and at an eight-week follow-up.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)