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临床试验/NCT04249921
NCT04249921Unknown不适用

Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年11月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
试验地点
1
主要终点
WHOQOL-BREF Taiwan Version

研究概览

简要总结

Skull base tumors are a type of tumor that grow in the area of several skulls behind the cranial cavity. The incidence rate is 2 to 18 per 100,000 people per year; males and females are likely to have a proportional difference in the types of skull base tumors.

Cerebellopontine angle (CPA) tumors are the most common neoplasms in the posterior skull base,accounting for 5-10% of skull base tumors.Some different kinds of tumors can grow in cerebellopontine angle. The tumors are more likely to cause some symptoms when they grow large enough to put pressure on the brain.

A common traditional treatment for skull base tumors is neurosurgery-craniotomy. However, after the operation, brain may be injured with hematoma, and the instruments used are in contact with the brain. It is still inevitable that there will have complications of minor and major nerve damages, such as facial paralysis,trigeminal neuralgia, tinnitus, sports disorders (ataxia) and so on.

Acupuncture has a unique effect on the treatment of the human nervous system. Aim of the study is used acupuncture to improve the complications of the surgery of Cerebellopontine angle tumors in skull base.

详细描述

Skull base has clinically unique importance:it is the anatomic junction of the neural and facial viscerocranium,supports human brain and supports that contains the neurovascular structures entering or exiting the skull,it divided into anterior,middle and posterior skull base.Skull base tumors are a type of tumor that grow in the area of several skulls behind the cranial cavity ,tumors most grow inside the skull base, and a few are formed outside because the tumor may originate from the base of skull or elsewhere in the body (metastatic).The incidence rate is 2 to 18 per 100,000 people per year; males and females are likely to have a proportional difference in the types of skull base tumors.

Cerebellopontine angle (CPA) tumors are common skull base tumors in posterior skull base. CP angle located below the cerebrum, between the pons and the cerebellum and between the superior and inferior limbs of the cerebellopontine fissure, it is a V-shaped angular cleft. About 6%-10% of skull base tumors are in the cerebellopontine angle (CPA). 90% of tumors in this area(CPA) are vestibular schwannoma (acoustic neuromas), 3% are meningioma, and the rest are primary cholesteatoma (lipoma),facial nerve schwannoma ,angioma as well as arachnoid cyst etc..

At present, computed tomography (CT) and nuclear magnetic resonance imaging (MRI) can be used to detect and evaluate skull base lesions. When these tumors grow enough to compress the nerves around the brain, the areas where the tumor are pressed could cause some symptoms such as blurred vision, headache, dizziness and other specific symptoms that affect normal life.

A common traditional treatment for skull base tumors is neurosurgery-craniotomy. However, after the operation, the brain may be injured with hematoma, and the instruments used are in contact with the brain. It is still inevitable that there will have complications of minor and major nerve damages, such as facial paralysis and trigeminal neuralgia, tinnitus, sports disorders (ataxia) and so on. If the damages are in serious situations, patients are also possible to be serious infected or in a vegetative state.

Acupuncture has a unique effect on the treatment of the human nervous system. Acupuncture mainly aims to improve the complications of the surgery of Cerebellopontine angle tumors in skull base by eliminating blood stasis, clearing meridians, and strengthening the body.The researchers' selections of acupoints are distributed in Large Intestine,Stomach Meridian,Small Intestine Meridian,Triple Energizer Meridian and Gallbladder Meridian in body.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • The patients who have been diagnosed Cerebellopontine Angle Tumor by neurosurgeons.
  • The Patients who have been undergoned the surgery of tumor
  • Not receiving acupuncture for other diseases (needle stimulate for body ) or any rehabilitation treatment at the same time
  • Voluntary participation in this study

排除标准

  • Taking anticoagulant drugs or who have coagulopathy
  • Pregnant women, especially pregnant women with habitual abortion
  • Skin infections
  • Acupuncture phobia (this study has invasive treatment: acupuncture)

结局指标

主要结局

WHOQOL-BREF Taiwan Version

时间窗: 8 weeks

Evaluate the quality of life after acupuncture treatment, use WHOQOL-BREF Taiwan Version questionnaire. Scale: 0\~100, higher scores, better life quality. Counted by each time recording and using mode conversion to get final scale.

Visual Analogue Scale: VAS

时间窗: 8 weeks

measurement for pain,to assess the pain degree. Scale: 0\~100 mm, higher scores, higher pain . Counted by each time recording.

Functional Assessment of Cancer Therapy: General(FACT-G)

时间窗: 8 weeks

Evaluate the quality of life for " the patients of CPA tumor in skull base " after acupuncture treatment,there are four parts,physiology,social and family, emotion,function.Scale: 0\~100, higher scores, better life quality. Counted by each time recording and using mode conversion to get final scale.

House-Brackmann grading scale

时间窗: 8 weeks

measurement and evaluate the level for the patients of facial paralysis after surgery of CPA tumor in skull base.Measure the upwards and outwards movement situation of eyebrows and mouth. Each reference point scores 1 point for each 0.25 cm movement, up to a maximum of 1 cm. The scores are then added together, to give a number out of 8.After that, the scale of facial paralysis corresponding to the score was divided into five levels, with the first level being the mildest and the fifth level being the most severe.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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