Clinical trial NCT04249921: Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base
Official title: Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acupuncture
Tumor, Brain
Skull Base Tumor
Cerebellopontine Angle Tumor
Complication of Treatment
Quality of Life
Neuromuscular Blockade
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-01-31
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients of cerebellopontine angle (CPA) tumors in skull base.

Brief summary: 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.

Detailed description: 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.

In the past, some researchers used questionnaires for the quality of life of skull base tumor surgery, and also some researchers used questionnaires to evaluate the efficacy of acupuncture. The rationale of the study is to combine these three-the surgery of CP Angle tumor in skull base,acupuncture and questionnaires.Namely,the researchers use four questionnaires to evaluate the efficacy of acupuncture after surgery of Cerebellopontine Angle tumor in skull base.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: WHOQOL-BREF Taiwan Version
timeFrame: 8 weeks
measure: Visual Analogue Scale: VAS
timeFrame: 8 weeks
measure: Functional Assessment of Cancer Therapy: General(FACT-G)
timeFrame: 8 weeks
measure: House-Brackmann grading scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Center for Traditional Medicine, Taipei VGH
Study officials:
affiliation: tpwu@vghtpe.gov.tw
name: Ta-Peng Wu, MD/Master
role: STUDY_DIRECTOR
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