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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of Rzeszow

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality-Assisted Rehabilitation

    Other intervention

    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

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Virtual Reality-Assisted RehabilitationExperimental treatment 1 intervention
Group B: Conventional RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
2

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.

Time frame
Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
3

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.

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

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.

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

Secondary outcomes

1

Functional disability measured using the Oswestry Disability Index (ODI)

Assessment of disability related to low back pain using the Oswestry Disability Index questionnaire. The total score ranges from 0 to 100, with higher scores indicating greater disability.

Time frame
Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
2

Pain intensity measured using the Numeric Rating Scale (NRS)

Assessment of pain intensity using the Numeric Rating Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
3

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

Assessment of functional limitations associated with low back pain using the Roland-Morris Disability Questionnaire. Scores range from 0 to 24, with higher scores indicating greater disability.

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

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

Assessment of fear of movement related to pain using the Tampa Scale of Kinesiophobia (TSK-11). Scores range from 11 to 44, with higher scores indicating greater fear of movement.

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

Other outcomes

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