Pretreatment With Electroacupuncture to Reduce Discomfort

NCT ID: NCT02077270

Last Updated: 2015-11-17

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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electroacupuncture

patients in whom precolonoscopic electroacupuncture is preformed

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type PROCEDURE

Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),

Sham electroacupuncture

sham electroacupuncture

Group Type PLACEBO_COMPARATOR

electroacupuncture

Intervention Type PROCEDURE

Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),

No intervantion

no intervantion

Group Type SHAM_COMPARATOR

electroacupuncture

Intervention Type PROCEDURE

Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),

Interventions

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electroacupuncture

Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Dan Carter, Gastroenterologist

GI consult

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Dan Carter, MD

Role: CONTACT

97235302197

Eytan Bardan, MD

Role: CONTACT

97235303130

Facility Contacts

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Dan Carter, MD

Role: primary

97235302197

Eytan Bardan, MD

Role: backup

97235303660

Other Identifiers

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SHEBA-14-9733-DC-CTIL

Identifier Type: -

Identifier Source: org_study_id