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临床试验/NCT03572855
NCT03572855Unknown不适用

The Effect of Peak Scoliosis Spinal Bracing System on Gait and Pain Level in Adult Scoliosis Patients

Texas Back Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Kinematic Variables Change assessed with human motion capture system

研究概览

简要总结

Degenerative adult scoliosis (ADS) results from age related changes leading to segmental instability, deformity and stenosis. Patients with scoliosis demonstrate an altered gait pattern.Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. Bracing has been found to reduce pain within a short time in ADS patients. A new brace has recently become available, the Peak™ Scoliosis Brace (Aspen Medical Products), designed to alleviate pain in adult patients with chronic pain secondary to scoliosis. The purpose of this study is to investigate the impact of spinal bracing using Peak™ Scoliosis Brace on pain and lower extremities kinematics of gait.

详细描述

Degenerative adult scoliosis (ADS) results from age related changes leading to segmental instability, deformity and stenosis. Although the etiology is unclear, degenerative adult scoliosis is associated with progressive and asymmetric degeneration of the disc and facet joints, which typically leads to stenosis. By virtue of the narrowed spinal canal associated with the degeneration these patients frequently develop back pain, as well as leg pain, weakness, and numbness. With an aging population in the USA and an increased attention to quality of life versus cost issues in the current healthcare environment, degenerative adult scoliosis has become a considerable healthcare concern.

Patients with scoliosis demonstrate an altered gait pattern.Such differences include decreased step length and reduced range of motion in the upper and lower extremities asymmetry of trunk rotation and ground reaction force in three-dimensions. Previous research found a decrease in the muscular mechanical work associated with an increase of energy cost and a decrease in the muscular efficiency in a scoliosis population compared to healthy controls. Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. This altered gait pattern demonstrated by subjects with scoliosis may be due to changes in global postural control strategies caused by pain and the spinal deformity.

Previous research showed that scoliosis patients do not have impaired postural balance when compared to healthy controls, while several others did find an effect of scoliosis on postural balance. This discrepancy in findings may be due to differences in curve characteristics included and their effects on postural balance, curve types (single or double), number of different curve types, location of curves (thoracic and lumbar), and/or Cobb angles.

Bracing has been found to reduce pain within a short time in ADS patients. Custom-made rigid torso braces, similar to those commonly used for children, are sometimes used in ADS patients; however, only anecdotal evidence of their efficacy is available and problems with comfort and compliance are quite frequent. A new brace has recently become available, the Peak™ Scoliosis Brace (Aspen Medical Products), designed to alleviate pain in adult patients with chronic pain secondary to scoliosis. The Peak Scoliosis Brace led to some improvement of pain at 1 month in a group of adult women with scoliosis and chronic low back pain, but the quality of life did not change significantly. This is may be due to the very short follow-up time. The effect of these braces on functional tasks and activities of daily living including walking have not been studied either.

The purpose of this study is to investigate the impact of spinal bracing using Peak™ Scoliosis Brace on pain and lower extremities kinematics of gait.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30- 75 years and older
  • Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
  • Able to ambulate without assistance and stand without assistance with their eyes open for a minimum of 10 seconds
  • Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-treatment follow-up

排除标准

  • History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
  • Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
  • BMI higher than 35
  • Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
  • Major trauma to the pelvis
  • Pregnant or wishing to become pregnant during the study

研究组 & 干预措施

Scoliosis Brace

Experimental

The Peak Scoliosis Brace designed to alleviate pain in adult patients with chronic pain secondary to scoliosis.

干预措施: Scoliosis Brace (Combination Product)

结局指标

主要结局

Kinematic Variables Change assessed with human motion capture system

时间窗: Baseline; 45 minutes and 2 moths after bracing

3-Dimensional Range of Motion (ROM) during the stance and swing phase of the spine, pelvis, hip, knee, ankle, shoulder, and elbow joint angles along with center of mass and head sway and displacement

次要结局

  • Spatio-Temporal Variables Change assessed with human motion capture system(Baseline; 45 minutes and 2 moths after bracing)
  • Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).(Baseline; 45 minutes and 2 moths after bracing)
  • Patient Self-Reported Outcome Assessments Change - Visual analog scale (VAS)(Baseline; 45 minutes and 2 moths after bracing)
  • Patient Self-Reported Outcome Assessments Change - Scoliosis Research Society (SRS22)(Baseline; 45 minutes and 2 moths after bracing)
  • Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK).(Baseline; 45 minutes and 2 moths after bracing)
  • Patient Self-Reported Outcome Assessments Change - Fear Avoidance Beliefs Questionnaire (FABQ)(Baseline; 45 minutes and 2 moths after bracing)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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