Acupuncture Treatment in Adults Undergoing Diagnostic OGD : A Double-Blind Placebo Controlled Randomized Trial

NCT ID: NCT00449241

Last Updated: 2007-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-07-31

Brief Summary

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To find out how the application of acupuncture needles to the proposed acupuncture points: Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during Esophago-gastro-duodenoscopy (EGD)

Detailed Description

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Acupuncture is being used as one part of Chinese medicine for more than 2,500 years in treating diseases. Recent functional magnetic resonance imaging demonstrated that acupuncture can suppress the "pain" area in the brain so as to reduce the pain that felt by human subjects. Western medicine proposed the acupuncture mechanisms as to "provoke the release of endogenous substances" from central nervous system so in reducing pain. Many studies had been done using acupuncture in reducing pain for post-operation period, however, most of them were not very systematic and even some of them are leak of control group. Furthermore, to our knowledge, the use of acupuncture for reducing anxiety during EGD has not been previously investigated.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Acupuncture

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-70 undergoing elective unsedatant diagnostic EGD
* belonging to American Society of Anesthesia (ASA) classes 1 to 2

Exclusion Criteria

* History of gastrectomy, esophagectomy, Whipple's operation and other gastrointestinal operations
* ASA class 3 to 4
* Pregnancy
* Allergy to acupuncture needles
* Request sedation
* Previous experiences of EGD
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

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Wing Wa Leung, Master

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, CUHK

Locations

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Combined Endoscopy Centre, Alices Ho Miu Ling Netherole Hospital

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wing Wa Leung, Master

Role: CONTACT

Facility Contacts

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Wing Wa Leung, Master

Role: primary

Other Identifiers

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CRE-2006.227-T

Identifier Type: -

Identifier Source: org_study_id

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