跳至主要内容
临床试验/NCT05115461
NCT05115461Enrolling By Invitation不适用

Postural Stability in Patients With Lumbar Radiculopathy and it's Relation to Neuropathic Pain: a Cross Sectional Case-control Study

Bozyaka Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
80
试验地点
1
主要终点
Dynamic Postural Stability

研究概览

简要总结

The aim of this study is to answer the questions below;

  1. Is there a difference between patients with lumbar radiculopathy suffering from radicular pain and healthy subjects in terms of static and dynamic postural stability?
  2. Is there a relationship between postural stability and the neuropathic characteristics of radicular pain?

详细描述

Patients presenting to our outpatient clinic with radicular pain and MRI findings associated with radiculopathy will be tested for static and dynamic postural stability. Patient demographics, pain intensity, neuropathic pain scores, and level of disability will also be recorded. The demographic data and postural stability scores will also be collected for the control subjects. Differences between the patient and control groups in terms of postural stability parameters will be sought. In addition, the relationship between the variables representing balance in the patient group and the neuropathic pain score and disability will be investigated.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having radicular pain due to lumbar disc herniation.
  • Root compression on the dominant side on imaging.
  • Root compression at no more than two levels.
  • Radicular pain with at least 3 points on a numerical rating scale.

排除标准

  • No radicular pain despite root compression on imaging.
  • Midline disc herniation or root compression on the nondominant side.
  • Radicular pain on the non-dominant side.
  • Treatment with neuropathic pain medication or psychotropic medication.
  • Loss of muscle strength on clinical examination.
  • Evidence of lower extremity atrophy, joint contractures, shortening of limbs, or similar disabilities.
  • Presence of vision loss, vestibular or neurological disorders that may cause balance disorders.

结局指标

主要结局

Dynamic Postural Stability

时间窗: Once, at baseline

Postural Stability Test will be performed via Biodex Balance System. This test assesses the patient's ability to maintain the center position (zero point) on a moving balance platform. The test protocol is performed with the following parameters: Duration: 20 seconds, Stability Level: 8, and Stance: two legs. Patients will complete a 1-minute pre-test trial to get used to the device. Then the test will be performed with 3 trials. The patient's performance will be noted as the overall stability index. A high stability index value indicates poor balance and stability.

Static Postural Stability

时间窗: Once, at baseline

Postural Stability Test will be performed via Biodex Balance System. This test assesses the patient's ability to maintain the center position (zero point) on a stable platform. The test protocol is performed with the following parameters: Duration: 20 seconds, Stability Level: Static, and Stance: both legs, alternating. Patients will complete a 1-minute pre-test trial to get used to the device. Then the test will be performed with 3 trials. The patient's performance will be noted as the overall stability index. A high stability index value indicates poor balance and stability.

次要结局

  • Neuropathic pain(Once, at baseline)
  • Disability(Once, at baseline)

研究者

发起方
Bozyaka Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Buğra İnce

Assoc. Prof

Bozyaka Training and Research Hospital

研究点 (1)

Loading locations...

相似试验