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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postural stability measured using center of pressure path length
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Conventional 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.
干预措施: Conventional Rehabilitation (Other)
Virtual Reality-Assisted Rehabilitation
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.
干预措施: Virtual Reality-Assisted Rehabilitation (Other)
结局指标
主要结局
Postural stability measured using center of pressure path length
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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).)
- 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).)
- 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).)
- Perceived stress measured using the Perceived Stress Scale (PSS-10)(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)(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(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)(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)(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)(Baseline, Week 4 (end of the rehabilitation program), and Week 12 (8 weeks post-treatment follow-up).)
研究者
Michał Pastyrzak
Principal Investigator
University of Rzeszow