Electroacupuncture and Trancutaneous Electrical Nervous Stimulation (TENS) for Colonoscopy Analgesia

July 11, 2011 updated by: Azienda Per I Servizi Sanitari N. 2 Isontina

Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy: a Prospective, Randomized, Controlled Study

To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation (TENS) in reducing patient's discomfort during colonoscopy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluation patient's pain and discomfort during colonoscopy, using two non invasive analgesic methods.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Gorizia, Italy, 34170
        • Presidio Ospedaliero di Gorizia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients scheduled for colonoscopy and in whom deep sedation was not planned will be included in the study

Exclusion Criteria:

  • age > 80 and less than 18 years old, severe cardiac or pulmonary disease, anticoagulant, benzodiazepines, antidepressants, opiates therapies, severe cognitive impairment, uncontrolled hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
Other: Acupuncture
Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
Other Names:
  • Electroacupuncture
Experimental: transcutaneous electrical stimulation
Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
Other: Transcutaneous electrical stimulation
Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
Other Names:
  • TENS
No Intervention: Control
patient are monitored for pain and discomfort
Other: Control
Patients are monitored for pain and discomfort
Other Names:
  • No treatment (only sedative drugs if request)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of patients' discomfort and pain during and at the end of colonoscopy both in acupuncture group and in TENS group compare with controls.
Time Frame: During colonoscopy, we'll evaluate pain at colorectal, left, trasversal and right colon position of colonscope. At the end of colonoscopy, before discharge, we' ll evaluate patient's general discomfort.
During colonoscopy, we'll evaluate pain at colorectal, left, trasversal and right colon position of colonscope. At the end of colonoscopy, before discharge, we' ll evaluate patient's general discomfort.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Per I Servizi Sanitari N. 2 Isontina

Investigators

  • Principal Investigator: Corrado Thomann, MD, ICU Gorizia Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34115/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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