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

November 12, 2010
July 11, 2011
November 2010
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01247935 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Electroacupuncture and Trancutaneous Electrical Nervous Stimulation (TENS) for Colonoscopy Analgesia
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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Pain
  • Other: Acupuncture
    Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
    Other Name: Electroacupuncture
  • Other: Transcutaneous electrical stimulation
    Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
    Other Name: TENS
  • Other: Control
    Patients are monitored for pain and discomfort
    Other Name: No treatment (only sedative drugs if request)
  • Experimental: Acupuncture
    Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
    Intervention: Other: Acupuncture
  • Experimental: transcutaneous electrical stimulation
    Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
    Intervention: Other: Transcutaneous electrical stimulation
  • No Intervention: Control
    patient are monitored for pain and discomfort
    Intervention: Other: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01247935
34115/14
No
Corrado Thomann, Azienda per i Servizi Sanitari n. 2 Isontina
Azienda Per I Servizi Sanitari N. 2 Isontina
Not Provided
Principal Investigator: Corrado Thomann, MD ICU Gorizia Hospital
Azienda Per I Servizi Sanitari N. 2 Isontina
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP