跳至主要内容
临床试验/NCT01862705
NCT01862705已完成不适用

Using fMRI to Determine if Cerebral Hemodynamic Responses to Pain Change Following Thoracic Spine Manipulation in Individuals With Mechanical Neck Pain

OSF Healthcare System2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
BOLD response to noxious stimuli

研究概览

简要总结

Thoracic spine thrust manipulation (TSM) has been shown to be an effective intervention in the management of patients with neck pain. However the mechanisms for pain relief associated with this intervention remain largely unexplained. Recent evidence suggests structures within the brain may have a role in creating responses of pain relief. This study aims to use functional magnetic resonance imaging (fMRI) to determine if there is a change in blood flow to structures within the brain following TSM in patients with neck pain. All patients will undergo fMRI while receiving painful stimuli directed to two separate sites, the cuticle of the index finger and the great toe. Subjects will then receive either TSM or sham-manipulation and then immediately undergo a second fMRI scan receiving the same painful stimuli. The primary outcome of interest is the shift in blood flow within the brain before and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD) technology. This study will be the first to examine this type of response to manual therapy within the brain in patients with neck pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

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

  • Primary complaint of mechanical neck pain of less than 6 weeks in duration as identified in the patient's initial physical examination. Mechanical neck pain is defined as generalized neck and/or shoulder, peri-scapular pain with symptoms provoked by neck postures, neck movements, or palpation of the cervical musculature

排除标准

  • Any medical red flags suggestive of non-musculoskeletal origin of pain, such as metabolic disorders, osteoporosis, tumor, and/or rheumatoid arthritis
  • No contraindications to spinal mobilization
  • No contraindications to MRI (claustrophobia, presence of cardiac pacemakers, cochlear implants, metal implants, implanted hearing aids, and previous injuries caused by bullets or shrapnel, pregnancy or thought to be pregnant

结局指标

主要结局

BOLD response to noxious stimuli

时间窗: Immediately following TSM or sham-manipulation. Time frame to initiate MR scanning following thrust or sham-manipulation not to exceed 5 minutes.

shift in blood flow within the brain before and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD) technology, as measured by fMRI.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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