Effect of Osteopathic Techiniques on Intraocular Pressure
2021年11月21日 更新者:Rodolfo Amoroso Borges、Federal University of São Paulo
Effect of Osteopathic Techiniques on Intraocular Pressure: a Randomized Double-blind Clinical Trial
The purpose of this study is to assess the effects osteopathic techniques at the upper cervical vertebrae or at the sphenopalatine ganglia on the intraocular pressure.
研究概览
详细说明
The 7 volunteers will be randomized into 3 groups and there will be an experimental group 1 that will receive a technique of manipulation of the upper cervical, an experimental group 2 that will receive a technique of manipulation of the sphenopalatine ganglion and a control group that will not receive any intervention.
Each volunteer will participate in the 3 groups.
There will be 4 assessments, one before the procedure and one just after each procedure, including the control.
研究类型
介入性
注册 (实际的)
7
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
São Paulo
-
Jundiaí、São Paulo、巴西、13208-120
- Escola Superior de Educação Física
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Intraocular pressure below 21mmHg
Exclusion Criteria:
- Positive Klein test
- Use of medications that affect the circulatory system in up to one month before the procedures;
- Caffeine use 24 hours before procedures;
- Presence of ophthalmic diseases;
- History of hypertension or diabetes;
- Blindness;
- Tumor in the head;
- Skull or cervical fractures that occurred less than 6 months ago.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Upper cervical manipulation group
The patient will be in the supine position.
The cephalic hand will make contact with one side of the patient's skull, leaving the sternocleidomastoid muscle between the third and fourth fingers.
The caudal hand will make global contact with the patient's skull on the opposite side.
The therapist should place his torso on the patient's head, leaving the two forearms aligned with the axis of the patient's spine, as this technique is applied to the axis of the odontoid process of the ax.
With neutral flexion-extension the therapist will place the rotation parameter to the opposite side (70-80 degrees) and a small contralateral inclination.
Then it will search for the driving barrier with a small axial traction movement.
When the driving barrier is found, the thrust should be applied in a helical direction, increasing rotation and traction.
It will be applied bilaterally.
|
The patient will receive an upper cervical manipulation as described in the Experimental Group 1.
|
|
实验性的:Sphenopalatine ganglion group
The patient will be supine on the bench and the therapist with gloves will sit next to the patient contralateral to the manipulated sphenopalatine ganglion (SPG).
One of the therapist's hands will be placed flat in contact with the apex of the patient's head to stabilize it.
The patient will be instructed to open his mouth and deviate the mandible laterally to the same side of the ganglion to be treated.
The therapist will then apply pressure to the SPG with the fifth finger of your other hand in the patient's mouth, moving up along the alveolar process of the maxilla teeth to reach the pterygoid process.
The therapist will keep the patient's head elevated until the lateral pterygoid muscle relaxes.
Then, the pressure will be applied into the pterygopalatine fossa.
The therapist will then apply gentle pressure on the SPG with the pulp of the fifth finger until tissue relaxation.
He will then release the contralateral SPG in the same way.
|
The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.
|
|
无干预:Control Group
The patient will lie down on the bench for 10 minutes.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of the intraocular pressure after upper cervical manipulation
大体时间:Immediately after the intervention and 30 minutes after the intervention
|
After this manipulation, it is expected that there will be a sympathetic response increasing the intraocular pressure.
|
Immediately after the intervention and 30 minutes after the intervention
|
|
Change of the intraocular pressure after sphenopalatine ganglion manipulation
大体时间:Immediately after the intervention and 30 minutes after the intervention
|
After this manipulation, it is expected that there will be a parasympathetic response decreasing the intraocular pressure.
|
Immediately after the intervention and 30 minutes after the intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年9月28日
初级完成 (实际的)
2021年11月9日
研究完成 (实际的)
2021年11月19日
研究注册日期
首次提交
2021年4月20日
首先提交符合 QC 标准的
2021年4月27日
首次发布 (实际的)
2021年4月28日
研究记录更新
最后更新发布 (实际的)
2021年12月2日
上次提交的符合 QC 标准的更新
2021年11月21日
最后验证
2021年11月1日
更多信息
与本研究相关的术语
其他研究编号
- RBorges
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.