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

NCT04249921 | Unknown

• 1 other identifier: 2019-09-001AU
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Tumor, Brain; Skull Base Tumor; Cerebellopontine Angle Tumor; Complication of Treatment; Quality of Life; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Experimental

1. Use acupuncture to treat the patients who received the surgery of CPA tumor. Acupoints of reference: Yifeng(TE17),Tinggong(SI19),Xiaguan(ST07),Wind Pool(GB20),Outer Pass(SJ5),Union Valley(LI4),Yang Mound Spring(GB34),Leg Three Li(ST36). 2. Use questionnaires to evaluate.The questionnaires including House-Brackmann Grading Scale,WHOQOL-BREF Taiwan Version,Functional Assessment of Cancer Therapy: General(FACT-G),Visual Analogue Scale(VAS).

Control

1.Use questionnaires to evaluate.The questionnaires including House-Brackmann Grading Scale,WHOQOL-BREF Taiwan Version,Functional Assessment of Cancer Therapy: General(FACT-G),Visual Analogue Scale(VAS).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients of cerebellopontine angle (CPA) tumors in skull base.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Center for Traditional Medicine, Taipei VGH

Taipei, 11217, Taiwan

RECRUITING

Related Publications (15)

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  PMID: 25745609 RESULT

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  PMID: 17562049 RESULT

• 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.

  PMID: 28811848 RESULT

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  PMID: 20592852 RESULT

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  PMID: 30666464 RESULT

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  PMID: 20592851 RESULT

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  PMID: 18769654 RESULT

• Xu S, Wang L, Cooper E, Zhang M, Manheimer E, Berman B, Shen X, Lao L. Adverse events of acupuncture: a systematic review of case reports. Evid Based Complement Alternat Med. 2013;2013:581203. doi: 10.1155/2013/581203. Epub 2013 Mar 20.

  PMID: 23573135 RESULT

• Chung A, Bui L, Mills E. Adverse effects of acupuncture. Which are clinically significant? Can Fam Physician. 2003 Aug;49:985-9.

  PMID: 12943357 RESULT

• Chen MH, Chen MH, Huang JS. Cervical subdural empyema following acupuncture. J Clin Neurosci. 2004 Nov;11(8):909-11. doi: 10.1016/j.jocn.2004.02.011.

  PMID: 15519876 RESULT

• Giovagnoli AR. Quality of life in patients with stable disease after surgery, radiotherapy, and chemotherapy for malignant brain tumour. J Neurol Neurosurg Psychiatry. 1999 Sep;67(3):358-63. doi: 10.1136/jnnp.67.3.358.

  PMID: 10449559 RESULT

• Zhang R, Wu T, Wang R, Wang D, Liu Q. Compare the efficacy of acupuncture with drugs in the treatment of Bell's palsy: A systematic review and meta-analysis of RCTs. Medicine (Baltimore). 2019 May;98(19):e15566. doi: 10.1097/MD.0000000000015566.

  PMID: 31083225 RESULT

• 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. Epub 2010 Sep 17.

  PMID: 20851113 RESULT

• 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.

  PMID: 24904885 RESULT

• 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 Med. 2019 Aug 15;2019:6073484. doi: 10.1155/2019/6073484. eCollection 2019.

  PMID: 31511780 RESULT

MeSH Terms

Conditions

Brain Neoplasms; Skull Base Neoplasms; Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skull Neoplasms; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases

Study Officials

• Ta-Peng Wu, MD/Master

  tpwu@vghtpe.gov.tw

  STUDY DIRECTOR

Central Study Contacts

Fang-Pey Chen, MD

CONTACT

+886976185588; fpchenchen@gmail.com

Kuan-Hung Lai, Master

CONTACT

+886985883794/+1315381-8619; godsbrave2013@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: January 31, 2020
• Study Start: November 20, 2019
• Primary Completion: October 4, 2020
• Study Completion: October 4, 2020
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

TW (1)