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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247935
First Posted: November 25, 2010
Last Update Posted: July 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Azienda Per I Servizi Sanitari N. 2 Isontina
  Purpose
To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation (TENS) in reducing patient's discomfort during colonoscopy

Condition Intervention
Pain Other: Acupuncture Other: Transcutaneous electrical stimulation Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy: a Prospective, Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Azienda Per I Servizi Sanitari N. 2 Isontina:

Primary Outcome Measures:
  • 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. ]

Enrollment: 60
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TENS
No Intervention: Control
patient are monitored for pain and discomfort
Other: Control
Patients are monitored for pain and discomfort
Other Name: No treatment (only sedative drugs if request)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247935


Locations
Italy
Presidio Ospedaliero di Gorizia
Gorizia, Italy, 34170
Sponsors and Collaborators
Azienda Per I Servizi Sanitari N. 2 Isontina
Investigators
Principal Investigator: Corrado Thomann, MD ICU Gorizia Hospital