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

This study has been completed.
Sponsor:
Information provided by:
Azienda Per I Servizi Sanitari N. 2 Isontina
ClinicalTrials.gov Identifier:
NCT01247935
First received: November 12, 2010
Last updated: July 11, 2011
Last verified: June 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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