An interventional study of Virtual Reality-Assisted Rehabilitation and Conventional Rehabilitation in Chronic Low Back Pain, sponsored by University of Rzeszow. Recruiting at 1 site in Poland. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by University of Rzeszow · Not applicable, Interventional, and Treatment
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.
Chronic low back pain is one of the most prevalent musculoskeletal disorders worldwide and represents a major public health problem due to its high socioeconomic burden and its impact on functional capacity, quality of life, and work ability. In addition to physical impairments, patients with chronic low back pain frequently present psychosocial factors such as fear of movement (kinesiophobia), stress, anxiety, and depressive symptoms, which may contribute to the persistence of pain and disability.
Conventional physiotherapy remains a cornerstone in the management of chronic low back pain. Treatment usually includes therapeutic exercises aimed at improving spinal mobility, postural control, muscular strength, balance, and functional movement patterns. Despite the effectiveness of exercise-based rehabilitation, maintaining patient motivation and long-term adherence to therapy may be difficult, particularly in individuals with persistent symptoms.
In recent years, virtual reality technologies have been increasingly explored as supportive tools in rehabilitation. VR systems allow the creation of interactive therapeutic environments that provide real-time visual and auditory feedback. This type of feedback may facilitate motor learning, improve movement quality, and increase patient engagement during therapy.
The aim of this study is to evaluate the effectiveness of rehabilitation supported by 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 participants aged 40-65 years diagnosed with chronic low back pain lasting at least three months.
The age range of 40-65 years was selected in order to reduce functional heterogeneity within the study population and to limit the influence of age-related factors on balance, mobility, and postural control. Individuals in this age group represent a population frequently affected by chronic low back pain while generally maintaining sufficient functional capacity to participate in a structured rehabilitation program.
Participants will be assigned to one of two groups: an experimental group receiving conventional rehabilitation supplemented with non-immersive virtual reality training and a control group receiving conventional rehabilitation alone. The rehabilitation program will last four weeks.
Participants will be monitored for potential adverse events during the rehabilitation program. Particular attention will be paid to symptoms potentially associated with the use of virtual reality, such as dizziness, nausea, visual discomfort, or increased pain. Any adverse events reported by participants or observed by the physiotherapist will be documented.
Adherence to the rehabilitation program will be monitored by recording attendance at each therapy session in a standardized therapy record maintained by the treating physiotherapist. The record will document the number of completed sessions and any missed sessions. Participants who do not complete the four-week rehabilitation program will not be included in the final analysis.
The rehabilitation program will be standardized for all participants. A predefined rehabilitation protocol will be used to ensure consistency of therapeutic procedures across participants and treatment sessions. All exercises will be performed under the supervision of a physiotherapist trained in the study protocol. The structure, duration, and intensity of the rehabilitation sessions will be comparable between groups, with the only difference being the replacement of a portion of conventional exercises with virtual reality-based training in the experimental group.
In the experimental group, part of the conventional exercises will be replaced by training using the Tecnobody Homing Studio system, a non-immersive virtual reality platform equipped with a three-dimensional camera enabling markerless motion analysis. The system allows real-time visualization of the patient's movements and provides visual and auditory biofeedback related to movement symmetry, joint mobility, and trunk control during task-oriented exercises.
A non-immersive virtual reality system was selected to ensure compatibility with routine clinical rehabilitation settings and to allow continuous supervision by the physiotherapist. Unlike immersive head-mounted display systems, non-immersive VR allows patients to maintain visual contact with the real environment, which facilitates movement correction and reduces the likelihood of disorientation or cybersickness. In addition, this type of system enables more natural performance of exercises involving full-body movement and postural control, which are particularly relevant in patients with chronic low back pain.
The virtual reality exercises will focus on improving movement quality, postural stability, coordination, and functional motor control. Exercises performed in the virtual environment will correspond in terms of movement patterns, involved body segments, and exercise intensity to those performed in the control group using conventional therapeutic exercises.
To ensure comparability between groups, the virtual reality training will replace a portion of the conventional exercises rather than being added as an additional intervention. This approach was adopted to maintain a comparable total duration and intensity of rehabilitation in both groups and to minimize the influence of differences in therapy dose on the study outcomes.
The estimated sample size of 80 participants was determined to provide sufficient statistical power to detect clinically meaningful differences between the study groups.
Outcome assessments will be conducted at three time points: before the beginning of the intervention, immediately after completion of the four-week rehabilitation program, and at an eight-week follow-up. The follow-up assessment was included to evaluate whether the effects achieved during rehabilitation are maintained after completion of the therapy.
The assessment protocol will include measurements of balance, posture, body composition, 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.
Functional assessments will include balance testing using the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), posture assessment through visual analysis supported by motion analysis software, body composition measurement using a Tanita body composition analyzer, joint mobility assessment through digital goniometry and the Otto-Schober test, and lower limb strength and endurance evaluation using the Sit-to-Stand Test. Pain intensity will be assessed using the Numeric Rating Scale (NRS), while pressure pain threshold will be measured using a digital algometer.
Psychosocial variables will include kinesiophobia assessed using the Tampa Scale of Kinesiophobia (TSK-11), perceived stress measured with the Perceived Stress Scale (PSS-10), anxiety and depression evaluated using the Hospital Anxiety and Depression Scale (HADS), functional disability assessed using the Oswestry Disability Index (ODI) and the Roland-Morris Disability Questionnaire (RMDQ), quality of life measured using the WHOQOL-BREF questionnaire, and motivation for physical activity assessed using an adapted intrinsic motivation questionnaire.
Statistical analysis will be performed using appropriate descriptive and inferential statistical methods, with the level of statistical significance set at p \< 0.05. In addition to the primary between-group comparisons, exploratory analyses will be conducted to examine potential associations between psychosocial factors (including kinesiophobia and perceived stress) and changes in functional motor outcomes. The design, conduct, and reporting of the trial will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomized controlled trials.
All collected data will be anonymized and stored securely. Access to the dataset will be restricted to authorized members of the research team in order to ensure confidentiality of participant information.
The results of the study are expected to contribute to the growing body of evidence on the use of virtual reality in musculoskeletal rehabilitation and may support the integration of VR-based training into evidence-based rehabilitation programs for patients with chronic low back pain.
Participants will be randomly assigned to either the experimental or control group using a computer-generated randomization sequence with a 1:1 allocation ratio. Allocation concealment will be ensured using sealed, opaque, sequentially numbered envelopes prepared by an independent researcher not involved in participant recruitment or outcome assessment. After baseline assessment, the envelope corresponding to the participant's sequence number will be opened to reveal group allocation.
285 studies on the registry are indexed under Kinesiophobia; 91 are open to participants now.
This study's planned enrollment of 80 is above the median of 52 across 174 interventional studies indexed under Kinesiophobia.
Browse Kinesiophobia studies →University of Rzeszow is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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).
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).
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).
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
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).
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).
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).
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).
Quality of life measured using the WHOQOL-BREF questionnaire
Assessment of overall quality of life and health status using the WHOQOL-BREF questionnaire. Domain scores range from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
Perceived stress measured using the Perceived Stress Scale (PSS-10)
Assessment of perceived stress using the Perceived Stress Scale (PSS-10). The questionnaire evaluates the degree to which situations in one's life are appraised as stressful during the previous month. Scores range from 0 to 40, with higher scores indicating higher perceived stress levels.
Time frame: Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS)
Assessment of psychological distress using the Hospital Anxiety and Depression Scale (HADS). The instrument consists of two subscales measuring anxiety and depression. Each subscale ranges from 0 to 21, with higher scores indicating greater severity of anxiety or depressive symptoms.
Time frame: Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
Health-related quality of life measured using the EQ-5D-5L questionnaire
Assessment of health-related quality of life using the EQ-5D-5L questionnaire. The instrument evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level scale, where higher levels indicate greater problems. The questionnaire also includes a visual analogue scale (EQ-VAS) ranging from 0 to 100, where higher values indicate better perceived health status.
Time frame: Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
Pain severity and interference measured using the Brief Pain Inventory (BPI)
Assessment of pain severity and pain-related interference with daily functioning using the Brief Pain Inventory (BPI). The instrument evaluates pain intensity (worst, least, average, and current pain) and the degree to which pain interferes with daily activities such as mood, work, sleep, and social relations. Scores range from 0 to 10, with higher scores indicating greater pain severity or interference.
Time frame: Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
Pain intensity measured using the Visual Analog Scale (VAS)
Assessment of pain intensity using a Visual Analog Scale (VAS). Participants indicate their current pain level on a 100-mm line ranging from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate greater pain intensity.
Time frame: Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
Motivation for rehabilitation measured using the Adapted Motivation Scale (AMS)
Assessment of motivation for participation in rehabilitation using an adapted version of the Academic Motivation Scale (AMS). The questionnaire evaluates intrinsic motivation, extrinsic motivation, and amotivation related to participation in therapeutic exercise. Responses are recorded on a Likert scale, with higher scores indicating stronger motivation for participation in rehabilitation.
Time frame: Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).
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Start is estimated for Apr 2026; primary completion for Apr 2027, 12 months later.
Of 132 non-industry interventional studies with no phase under Kinesiophobia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 12 months is above that.
Counting every sponsor, half of 132 studies reached it within 8 months; a quarter within 4 and three quarters within 14.
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