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临床试验/NCT02667821
NCT02667821已完成不适用

Changes in Vertebral Artery and Cerebral Hemodynamics Following Various Head Positions & Cervical Manipulation in Patients With Chronic/Recurrent Neck Pain

Canadian Memorial Chiropractic College2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation

研究概览

简要总结

The Investigators are performing a study to determine, in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine movements, including manipulation, in vivo using fMRI technology on vertebral and cranial blood flow dynamics affecting brain perfusion, and extend the current data set on these variables

详细描述

The goal of the study is to further investigate in patients with chronic/recurrent neck pain, the cerebrovascular hemodynamic consequences of cervical spine positions, including manipulation, in vivo under clinically relevant circumstances using two advanced MRI technology on the vertebral and posterior cerebral and cerebellar blood flow dynamics affecting brain perfusion. According to the knowledge of the investigators, a study utilizing MRI to examine blood flow and perfusion, turbulence and evidence of micro-trauma within these blood vessels has yet to be conducted.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • Adults aged 18 years and older with chronic/recurrent neck pain Grade II.
  • Must have been prescribed cervical spinal manipulation for treatment of their neck pain condition.

排除标准

  • A history of neck pain with associated arm pain within the last 6 months
  • Any current or history of neurologic symptoms including facial or extremity weakness, abnormal sensation to the face, body, or extremities, uncontrolled movements, abnormal gait, dizziness, unexplained nausea/vomiting, difficulty with speaking or swallowing
  • History of new or severe (Visual Analogue Scale >6) headaches in the last 3 months
  • Any contraindications to MRI
  • Any history of using drugs that affect blood flow such as Warfarin, or anti-coagulants.

研究组 & 干预措施

Intervention group

Experimental

Participants included in the experimental arm will be adults aged 18 years and older with chronic/recurrent neck pain Grade II who have been prescribed cervical manipulation for treatment of their condition. Each participant will undergo three separate test maneuvers consistent with prior work completed at the St. Joseph's Healthcare Hamilton Brain Body Institute. Each participant will begin with neutral cervical spine as a standard natural control, followed by block randomization between maximum voluntary rotation of the cervical spine and one cervical manipulation. Please see Intervention section for a detailed description.

干预措施: Head positions and spinal manipulation (Other)

结局指标

主要结局

Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation

时间窗: The series of fMRI sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.

Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood velocity (cm/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05

次要结局

  • Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.(The series of ASL sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.)

研究者

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

Nick Moser

Local contact investigator

Canadian Memorial Chiropractic College

研究点 (2)

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