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临床试验/NCT03784196
NCT03784196已完成不适用

Whiplash Associated Disorders - Sensory Changes During Rehabilitation

Universidad San Jorge1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Changes in Pressure Pain Thresholds

研究概览

简要总结

This study investigates the sensory profile of people suffering from whiplash associated disorders (WAD) during rehabilitation.

详细描述

Altered pain sensitivity is commonly reported in WAD populations when compared to a healthy control group but how/if this changes over time during rehabilitation is unclear. This study investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group suffering from WAD compared to a healthy control group.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No more than 3 weeks since MVA/WAD
  • WAD grade II defined by Quebec Task Force classification
  • Controls • Being healthy and free from any pain specific to the low back and/or in general

排除标准

  • Applies for both groups:
  • Pain related to a specific pathology such as spinal stenosis, metastasis, fracture, nerve lesions or injuries to the brain etc.
  • Previous painful condition (including neck pain) in the previous 6 months.
  • Prior surgery in the neck or shoulder area.
  • Radiculopathy.
  • Multiple painful sites/areas unrelated to the neck pain.
  • Operation to the spine.
  • Any neurological or systemic diseases which can affect the outcome measures.
  • Pregnancy.
  • Lack of ability to cooperate.
  • Additional exclusion criteria for Controls:
  • No current or previous history of on-going pain, defined as pain in the neck/shoulder region and/or elsewhere during the past 6 months.

结局指标

主要结局

Changes in Pressure Pain Thresholds

时间窗: Baseline, 2 weeks, 6 months

Changes in pressure pain thresholds will be determined with pressure algometry bilaterally over the neck and leg. PPT is defined as the exact time point where the pressure is first being perceived at painful.

Changes in Conditioned Pain Modulation

时间窗: Baseline, 2 weeks, 6 months

Changes in condition pain modulation (CPM) will be measures by recording PPT bilaterally over the neck and leg prior to and following a painful stimuli (a pressure cuff is inflated around the upper arm to create the conditioned stimulus). CPM value is calculated by subtracting raw PPT (without painful stimuli) from PPT under the conditioned stimulus.

次要结局

  • Neck Disability Index (NDI)(Baseline, 2 weeks, 6 months)

研究者

发起方
Universidad San Jorge
申办方类型
Other
责任方
Sponsor

研究点 (1)

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