Pretreatment With Electroacupuncture to Reduce Discomfort

Not Applicable

• Conditions: Pain
• Interventions: Procedure: electroacupuncture

• Registration Number: NCT02077270
• Lead Sponsor: Sheba Medical Center

Brief Summary

The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam.

Detailed Description

To assess the efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17
• Study Start: 2016-01
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult Patients referred for their first colonoscopy in the department of GI in Sheba, Tel Hashomer

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Exclusion Criteria

1. Ages <18y >75y
2. Any prior gastrointestinal endoscopy.
3. History of colonic resection.
4. Known or suspected stenosis of the colon.
5. Pregnancy.
6. Inflammatory bowel disease
7. Neuropsychiatric disorders or receiving psychotropic drugs.
8. Prior knowledge or experience of acupuncture.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electroacupuncture	electroacupuncture	patients in whom precolonoscopic electroacupuncture is preformed
Sham electroacupuncture	electroacupuncture	sham electroacupuncture
No intervantion	electroacupuncture	no intervantion

Primary Outcome Measures

Name	Time	Method
Efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy by measuring sedative drug amounts during colonoscopy	during the colonoscopy and in the hour post procedure	The measurement of the amount of drug added during colonoscopy

Secondary Outcome Measures

Name	Time	Method
Number of intra-examination adverse events.	from the begining of the endoscopy and up to 1 hour post procedure
Time of insertion till the cecum.	during colonoscopy	Time between insertion of the colonoscopy and the image of the cecum
Time of post-colonoscopy recovery as measured by the Aldrete score	up to 1 hour post colonoscopy
Patient's total satisfaction with the exam and the analgesia	between the end of the procedure and up to 1 hour post procedure

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel