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临床试验/NCT07242976
NCT07242976尚未招募不适用

Evaluation of Balance Using the Biodex Balance System Among Different Subcategories of Low Back Pain

Cairo University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Postural stability ( Overall Stability Index)

研究概览

简要总结

this study aims to evaluate balance using the biodex balance system among patients with spondylosis, spondylolisthesis, and lumber disc prolapse.

详细描述

Low back pain is one of the most common causes of disability globally . While postural balance impairments have been widely documented in individuals with low back pain, there is limited understanding of how these impairments vary across specific subcategories of specific low back pain. Low back pain is generally categorized into non specific and specific types.

Non-specific LBP approximately accounts for 85-90% of all low back pain cases (Hartvigsen et al., 2018). In contrast, specific low back pain arises from a recognizable pathology such as structural abnormalities. The most common causes of specific low back pain are lumbar spondylosis, spondylolisthesis, and lumbar disc prolapse. Lumbar spondylosis has a prevalence of 74% in individuals over 60 years confirmed with radiographic findings. Spondylolisthesis affects approximately 6-11.5% of adults , lumbar disc prolapse accounts for 2-5% of all low back pain cases.

Balance deficiency among patients with spondylosis, spondylolisthesis and lumber disc prolapse was reported in literature by different objective assessment tools. Individuals with low back pain exhibit measurable deficits in balance and postural stability compared to healthy controls . Also, the chronicity of low back pain affects both static and dynamic balance.

Assessment and detection of balance deficiency among patients with spondylosis, spondylolisthesis and lumber disc prolapse will allow physical therapists to design individualized rehabilitation programs. Improve understanding of interventions focusing on core stabilization, proprioceptive retraining and dynamic balance. This may improve postural control, enhance gait performance, reduce fall risk and support better functional outcomes in daily activities.

Thus, there was a need to study the difference in balance using the biodex balance system among patients with spondylosis, spondylolisthesis and lumber disc prolapse. The current study may provide a more conclusive insight in evaluation and treatment of patients with low back pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of chronic low back pain (≥3 months duration) (Ge et al., 2021). Referred from orthopedic surgeons with confirmed diagnosis of lumbar spondylosis, spondylolisthesis or lumber disc prolapse affecting L4-L5 or L5 S1( Hlaing et al., 2020) depending on imaging findings (MRI, CT or X-ray scan within the last 6 months):
  • Lumbar spondylosis; defined as degenerative disc disease, osteophyte formation with or without facet joint arthropathy (Natarajan et al., 2021; Christe et al., 2020).
  • Lumbar spondylolisthesis; defined as anterolisthesis of one vertebral body over another, graded via the Meyerding scale (grade 1 or 2) (Giordan et al., 2023; Chuang et al., 2018).
  • Lumbar disc prolapse; defined as protrusion, herniation of intervertebral disc (Kang et al., 2016; Hahne et al., 2019).
  • Age of patients ranges from 35 to 55 years (Albeshri, et.al., 2017)
  • Both genders will be included in the study
  • Pain intensity: ≥ 4/10 on a numerical pain rating scale (Thong et al., 2011).
  • BMI ranged from (18.5-29.9 kg/m²) (Karimi et al., 2008; Soliman et al., 2017).
  • Healthy subjects are healthy volunteers and without any Musculoskeletal disorders (Karimi et al., 2008).

排除标准

  • The following patients will be excluded from the study patients with:
  • Prior lumbar spine surgery or neurological disorders (e.g., parkinson's, stroke) that may influence balance (soliman et al., 2017).
  • Fractures of the spine, pelvis or lower extremities, (Karimi et al., 2008).
  • Leg length discrepancy(Karimi et al., 2008).
  • Systemic disease such as arthritis, tuberculosis, liver or kidney failure. (Karimi et al., 2008).
  • Patients with chronic non-specific low back pain.
  • Patients exhibiting red flag symptoms such as urinary or fecal incontinence, saddle anesthesia, progressive motor deficits (e.g., foot drop), or other signs of serious neurological compromis (Ruhe et al., 2011).
  • Participants experiencing low back pain with pain radiating distaly below the level of knee (Hlaing et al., 2020).

结局指标

主要结局

Postural stability ( Overall Stability Index)

时间窗: All postural assessments will be performed for 20 seconds

Postural stability will be assessed using the Biodex Balance System through the Overall Stability Index (OSI).The OSI reflects the degree of platform sway, with lower values indicating better balance control. Measurements will be taken under six standardized conditions to evaluate both static and dynamic balance performance. These conditions include: Double-Leg, Eyes Open (DLEO) Double-Leg, Eyes Closed (DLEC) Single-Leg, Eyes Open (SLEO) - Dominant Leg Single-Leg, Eyes Closed (SLEC) - Dominant Leg Single-Leg, Eyes Open (SLEO) - Non-Dominant Leg Single-Leg, Eyes Closed (SLEC) - Non-Dominant Leg

Postural Stability: Medial-Lateral Stability Index (MLSI)

时间窗: All postural assessments will be performed for 20 seconds

The Medial-Lateral Stability Index (MLSI) will be obtained from the Biodex Balance System to assess side-to-side postural control. Higher MLSI values indicate greater medial-lateral sway, while lower values reflect better stability in the frontal plane. the measurement will be in six conditions: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) Dominant leg, Single leg eye closed (SLEC) Dominant leg, Single leg eye open (SLEO) Non-Dominant leg and Single leg eye closed (SLEC) Non-Dominant leg

postural stability: Anterior-Posterior Stability Index (APSI)

时间窗: All postural assessments will be performed for 20 seconds

The Anterior-Posterior Stability Index (APSI) will be measured using the Biodex Balance System to evaluate forward-backward postural control. Lower APSI values indicate improved stability in the sagittal plane, whereas higher values reflect increased anterior-posterior sway. the measurement will be in six conditions: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) Dominant leg, Single leg eye closed (SLEC) Dominant leg, Single leg eye open (SLEO) Non-Dominant leg and Single leg eye closed (SLEC) Non-Dominant leg

Limits of Stability

时间窗: All postural assessments will be performed for 20 seconds

Limits of Stability will be assessed using the Biodex Balance System to evaluate the participant's ability to intentionally shift their center of gravity toward predefined targets without losing balance. The test measures directional control, reaction time, movement speed, and endpoint accuracy, with higher scores reflecting better dynamic balance and voluntary postural control. the measurement condition will be in Double leg eyes open (DLEO)

次要结局

  • Arabic version of Numerical pain rating scale (Ar-NPRS)(Periprocedural)
  • Arabic version of Oswestry disability index (Ar-ODI)(Periprocedural)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed El-sayed Muhammed Abu l Ftouh

Demonstrator at orthopedic department faculty of physical therapy delta university

Delta University for Science and Technology

研究点 (1)

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