Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:28 PM
Study NCT ID:
NCT07463105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality-Based Rehabilitation Versus Conventional Therapy in Patients With Chronic Low Back Pain
Sponsor:
University of Rzeszow
Organization:
Study Overview
Official Title:
Effects of Virtual Reality-Based Rehabilitation Compared With Conventional Physiotherapy on Motor and Psychosocial Function in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: