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

Condition(s) studied

Investigational drug(s) / intervention(s)

Virtual Reality-Assisted Rehabilitation: 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.

Conventional Rehabilitation: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Postural stability measured using center of pressure path length — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  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.
• Pressure pain threshold measured using digital algometry — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  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.
• Lower limb functional performance measured using the Sit-to-Stand test — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  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.
• Lumbar spine mobility measured using the Modified Schober Test — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  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.
• Postural stability measured using center of pressure sway area — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  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.
• Trunk posture and movement analysis measured using video motion analysis — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  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.
• Hip joint range of motion measured using digital goniometry — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  Assessment of hip joint mobility using digital goniometry. Range of motion will be measured in degrees (°). Higher values indicate greater hip joint mobility.
• Ankle joint range of motion measured using digital goniometry — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  Assessment of ankle joint mobility using digital goniometry. Range of motion will be measured in degrees (°). Higher values indicate greater ankle joint mobility.
• Body fat percentage measured using bioelectrical impedance analysis — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  Assessment of body fat percentage using bioelectrical impedance analysis performed with a Tanita body composition analyzer. Higher values indicate greater body fat percentage.
• Skeletal muscle mass measured using bioelectrical impedance analysis — Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
  Assessment of skeletal muscle mass using bioelectrical impedance analysis performed with a Tanita body composition analyzer. Higher values indicate greater skeletal muscle mass.

Trial sites (1)

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