Quality of Life Clinical Trial
Official title:
Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | October 4, 2020 |
Est. primary completion date | October 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Taiwan | Center for Traditional Medicine, Taipei VGH | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
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Bonneville F, Savatovsky J, Chiras J. Imaging of cerebellopontine angle lesions: an update. Part 1: enhancing extra-axial lesions. Eur Radiol. 2007 Oct;17(10):2472-82. Epub 2007 Jun 12. Review. — View Citation
Chen MH, Chen MH, Huang JS. Cervical subdural empyema following acupuncture. J Clin Neurosci. 2004 Nov;11(8):909-11. — View Citation
Chung A, Bui L, Mills E. Adverse effects of acupuncture. Which are clinically significant? Can Fam Physician. 2003 Aug;49:985-9. Review. — View Citation
Gil Z, Fliss DM. Quality of life in patients with skull base tumors: current status and future challenges. Skull Base. 2010 Jan;20(1):11-8. doi: 10.1055/s-0029-1242979. — View Citation
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Kim YD, Park JH, Yang SH, Kim IS, Hong JT, Sung JH, Son BC, Lee SW. Pain assessment in brain tumor patients after elective craniotomy. Brain Tumor Res Treat. 2013 Apr;1(1):24-7. doi: 10.14791/btrt.2013.1.1.24. Epub 2013 Apr 30. — View Citation
Kunimatsu A, Kunimatsu N. Skull Base Tumors and Tumor-Like Lesions: A Pictorial Review. Pol J Radiol. 2017 Jul 25;82:398-409. doi: 10.12659/PJR.901937. eCollection 2017. Review. — View Citation
Memari F, Hassannia F, Abtahi SH. Surgical Outcomes of Cerebellopontine angle Tumors in 50 Cases. Iran J Otorhinolaryngol. 2015 Jan;27(78):29-34. — View Citation
Qiu WQ, Claunch J, Kong J, Nixon EE, Fang J, Li M, Vangel M, Hui KK. The effects of acupuncture on the brain networks for emotion and cognition: an observation of gender differences. Brain Res. 2010 Nov 29;1362:56-67. doi: 10.1016/j.brainres.2010.09.040. — View Citation
Roser F, Dimostheni A, Elhammady MS, Recinos P, Rigante L. Response to: Phillips M. et al. "Safety of commercial airflight in patients with brain tumors: a case series". Journal of Neuro-Oncology (2018) 139:617-623. J Neurooncol. 2019 Apr;142(2):393-394. — View Citation
Witgert ME, Veramonti T, Hanna E. Instruments for estimation of health-related quality of life in patients with skull base neoplasms. Skull Base. 2010 Jan;20(1):5-10. doi: 10.1055/s-0029-1242978. — View Citation
Xiao X, Zheng Q, Shi Y, Zhang L, Zhao L, Zhou S, Zhang W, Cao W, Liu Y, Li Y. Association of Patients' Characteristics with Acupuncture Treatment Outcomes in Treating Bell's Palsy: Results from a Randomised Controlled Trial. Evid Based Complement Alternat — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WHOQOL-BREF Taiwan Version | 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. | 8 weeks | |
Primary | Visual Analogue Scale: VAS | measurement for pain,to assess the pain degree. Scale: 0~100 mm, higher scores, higher pain . Counted by each time recording. | 8 weeks | |
Primary | Functional Assessment of Cancer Therapy: General(FACT-G) | 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. | 8 weeks | |
Primary | House-Brackmann grading scale | 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. | 8 weeks |
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