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临床试验/NCT05249530
NCT05249530已完成不适用

Comparison of EEG Changes Over Time Following Application of Chiropractic Adjustive Force vs Non-force Simulation

Life University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月28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
30
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

The Life University Center for Chiropractic Research is conducting a research study to better understand the physiologic and brain-based differences between the touch and force components of the chiropractic adjustment. Eligible individuals will either receive a chiropractic adjustment with force or a non-force stimulation. Individuals in the force stimulation group will receive an active spinal adjustment with a handheld instrument called an Activator. Individuals in the non-force stimulation group will have one Activator placed on the spine and another Activator clicked away from the spine. This study is not randomized. The first participant will receive an active spinal adjustment, and the second participant will receive a non-force stimulation at the same locations as the first participant. This pattern repeats until all individuals have been recruited (n=30). Outcome assessments include resting state electroencephalography (EEG), electrocardiography (ECG), and blood pressure. Outcome assessments will be captured prior to the adjustment or non-force stimulation, after the adjustment or non-force stimulation, and one week later. Individuals will also undergo a standard health history and chiropractic physical exam at the start of participation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants will be masked to whether they are receiving an adjustment with force or a non-force stimulation

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

  • You are between the age of 18 and
  • You have not had a chiropractic adjustment in the past 2 weeks.
  • You are not currently receiving care such as acupuncture or physical therapy.
  • You are currently not taking any medication that may change your brain patterns.

排除标准

  • You do not have a history of recent spinal surgery or trauma.
  • You do not have any other health conditions that may prevent you from receive chiropractic care. This could include diagnosed osteoporosis.
  • You are not pregnant.
  • You do not have a severe mental health condition.
  • You do not have a known heart condition.

结局指标

主要结局

Blood pressure

时间窗: one-week follow up

Blood pressure will be captured using an automatic blood pressure cuff

Electroencephalography (EEG) Power spectrum

时间窗: One week follow up

64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.

Electrocardiogram (ECG) R-R intervals

时间窗: one-week follow up

Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.

次要结局

未报告次要终点

研究者

发起方
Life University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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