Investigation of the Effects of Vertebral Axial Loading Walking Training Added to Core Stabilization Exercises on Pain, Trunk Sensory Function, Muscle Strength and Endurance, Balance, and Proprioception in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from Baseline in Lumbar Proprioception (Active Joint Position Sense) After 6 Weeks of Intervention
研究概览
简要总结
Chronic low back pain is a common musculoskeletal condition persisting for more than three months and is associated with pain, functional limitations, impaired balance, altered proprioception, reduced trunk muscle performance, and decreased quality of life. Previous studies have demonstrated that individuals with chronic low back pain exhibit altered sensory input from spinal structures and impaired neuromuscular control, which may contribute to persistent pain and movement dysfunction. Although exercise-based physiotherapy approaches, particularly core stabilization exercises, are widely recommended and effective in the management of chronic low back pain, sensory deficits related to balance, proprioception, and body awareness are often insufficiently addressed in conventional rehabilitation programs.
Vertebral axial loading walking training is a functional rehabilitation approach involving slow, controlled walking under gentle vertical loading applied along the spinal axis. This intervention is thought to enhance afferent sensory input from spinal mechanoreceptors, potentially improving balance control, proprioception, and motor coordination. This randomized controlled study aims to investigate the effects of adding vertebral axial loading walking training to a standard core stabilization exercise program on pain intensity, balance, proprioception, trunk muscle strength and endurance, and body awareness in individuals with chronic low back pain.
详细描述
Chronic low back pain is one of the leading causes of disability worldwide and is characterized not only by persistent pain but also by impairments in postural control, proprioception, trunk muscle function, and body awareness. Neurophysiological studies have demonstrated that individuals with chronic low back pain exhibit altered afferent input from lumbar spinal structures and changes in central nervous system processing, resulting in impaired sensorimotor control and delayed trunk muscle activation. These alterations may negatively affect balance, movement coordination, and functional performance, thereby contributing to the chronicity of symptoms. Core stabilization exercises are commonly prescribed to improve trunk muscle strength, endurance, and neuromuscular control and have demonstrated beneficial effects in individuals with chronic low back pain. However, evidence suggests that traditional exercise programs may not sufficiently stimulate sensory receptors involved in proprioceptive input and postural regulation. Impaired proprioception and reduced body awareness have been identified as key factors associated with ongoing pain and functional limitations in this population. Vertebral axial loading walking training is a novel and functional intervention that applies gentle vertical loading along the spinal axis during slow and controlled walking. Axial loading is thought to stimulate spinal mechanoreceptors and enhance sensory feedback, thereby facilitating improved proprioceptive awareness, postural stability, and motor coordination during functional activities. This approach is practical, cost-effective, and easily integrated into rehabilitation settings. In this randomized controlled study, participants with chronic low back pain will be allocated to either a core stabilization exercise program alone or a combined intervention consisting of core stabilization exercises and vertebral axial loading walking training. Outcome measures will include pain intensity, balance performance, lumbar proprioception, trunk muscle strength and endurance, and body awareness. Assessments will be conducted at baseline and after the intervention period. The results of this study are expected to provide evidence for a more comprehensive rehabilitation strategy by integrating sensory-based and functional axial loading approaches into physiotherapy programs for individuals with chronic low back pain.
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
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30 to 55 years
- •Able to read and write
- •Not using regular medication during the study period
- •Voluntary participation and willingness to comply with study procedures
排除标准
- •Presence of lumbar radiculopathy or neurological deficits
- •Presence of specific spinal pathologies, including scoliosis, kyphosis, malignancy, fracture, infection, or inflammatory joint or bone diseases
- •Presence of major or chronic systemic diseases, including diabetes mellitus, rheumatoid arthritis, or systemic lupus erythematosus
- •Presence of any neurological disease, such as stroke, Parkinson's disease, or multiple sclerosis
- •Presence of any condition affecting balance, including cerebellar ataxia, vertigo, Ménière's disease, inner ear labyrinthitis, or vestibular neuritis
- •History of spinal surgery
- •History of minimally invasive spinal procedures or injections, including platelet-rich plasma (PRP), growth factor-rich plasma (GFRP), corticosteroids, or other pharmacological injections
- •History of major lower extremity surgery, including knee arthroplasty, hip arthroplasty, high tibial osteotomy, or meniscal surgery
- •Presence of lower extremity musculoskeletal injuries, including meniscal or ligament injuries or chronic ankle instability
- •Presence of lower extremity deformities, including talipes equinovarus, genu varum, genu valgum, or coxa vara/valga
- •Presence of cognitive impairment or diagnosed psychiatric disorders
- •Pregnancy or being less than 6 months postpartum
- •History of cancer or ongoing cancer treatment
- •Illiteracy
- •Failure to attend three consecutive treatment sessions
- •Receipt of physical therapy or rehabilitation within the past 6 months
研究组 & 干预措施
Core Stabilization Exercises plus Vertebral Axial Loading Walking Training (CSE+ALWT Group)
Participants in this group receive a standardized core stabilization exercise program combined with vertebral axial loading proprioceptive walking training. The intervention is supervised by a physiotherapist and applied three sessions per week for six weeks.
干预措施: Core Stabilization Exercises Plus Vertebral Axial Loading Walking Training (Behavioral)
Core Stabilization Exercises Only (CSE Group)
Participants in this group receive the standardized core stabilization exercise program alone, supervised by a physiotherapist, three sessions per week for six weeks.
干预措施: Exercise - Core Stabilization Exercise Program (Behavioral)
结局指标
主要结局
Change from Baseline in Lumbar Proprioception (Active Joint Position Sense) After 6 Weeks of Intervention
时间窗: Baseline and 6 weeks
Lumbar proprioception will be assessed by measuring active joint position sense during trunk flexion, lateral flexion, and extension using MATLAB-based angle analysis. The absolute angular error (in degrees) between the target position and the reproduced position will be calculated. Angular error is recorded in degrees, starting from 0° upward. Lower values indicate better proprioceptive accuracy. Higher values indicate impaired proprioception.
Change from Baseline in Pain Intensity at Rest and During Activity After 6 Weeks
时间窗: Baseline and 6 weeks
Pain intensity will be assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less pain.
Change from Baseline in Lumbar Pressure Pain Threshold After 6 Weeks
时间窗: Baseline and 6 weeks
Pressure pain threshold will be measured using a handheld algometer (Algometer commander, JTech Medical) and recorded in kg/cm². Higher values indicate greater pain tolerance, while lower values indicate increased pain sensitivity.
Change from Baseline in Trunk and Hip Muscle Strength After 6 Weeks
时间窗: Baseline and 6 weeks
Isometric muscle strength of trunk and hip muscles will be assessed using a digital hand-held dynamometer (Lafeyette Instrument®, Lafayette, IN) during maximal voluntary isometric contraction. Strength values are recorded in Newtons (N) or kilograms (kg). Higher values indicate greater muscle strength
次要结局
- Change from Baseline in Functional Disability Assessed by the Oswestry Disability Index After 6 Weeks(Baseline and 6 weeks)
- Change from Baseline in Health-Related Quality of Life Assessed by the EQ-5D-5L After 6 Weeks(Baseline and 6 weeks)
- Change from Baseline in Balance Performance Assessed by the Fullerton Advanced Balance Test After 6 Weeks(Baseline and 6 weeks)
- Change from Baseline in Postural Alignment Assessed by the New York Posture Rating Scale After 6 Weeks(Baseline and 6 weeks)
- Change from Baseline in Trunk Muscle Endurance After 6 Weeks(Baseline and 6 weeks)
- Change from Baseline in Kinesiophobia Assessed by the Tampa Scale of Kinesiophobia After 6 Weeks(Baseline and 6 weeks)
- Change from Baseline in Lumbar Range of Motion After 6 Weeks(Baseline and 6 weeks)
- Change from Baseline in Trunk Sensory Function After 6 Weeks(Baseline and 6 weeks)
研究者
Nilay Kalender
Physiotherapist
Hacettepe University