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

NCT ID: NCT01247935

Last Updated: 2011-07-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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

Detailed Description

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

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

NONE

Study Groups

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Acupuncture

Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy

transcutaneous electrical stimulation

Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy

Group Type EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type OTHER

Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy

Control

patient are monitored for pain and discomfort

Group Type NO_INTERVENTION

Control

Intervention Type OTHER

Patients are monitored for pain and discomfort

Interventions

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Acupuncture

Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy

Intervention Type OTHER

Transcutaneous electrical stimulation

Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy

Intervention Type OTHER

Control

Patients are monitored for pain and discomfort

Intervention Type OTHER

Other Intervention Names

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Electroacupuncture TENS No treatment (only sedative drugs if request)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Per I Servizi Sanitari N. 2 Isontina

OTHER

Sponsor Role lead

Responsible Party

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Azienda per i Servizi Sanitari n. 2 Isontina

Principal Investigators

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Corrado Thomann, MD

Role: PRINCIPAL_INVESTIGATOR

ICU Gorizia Hospital

Locations

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Presidio Ospedaliero di Gorizia

Gorizia, , Italy

Site Status

Countries

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Italy

References

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Sung JJ. Acupuncture for gastrointestinal disorders: myth or magic. Gut. 2002 Nov;51(5):617-9. doi: 10.1136/gut.51.5.617.

Reference Type BACKGROUND
PMID: 12377792 (View on PubMed)

Camilleri M. Editorial: is adequate relief fatally flawed or adequate as an end point in irritable bowel syndrome? Am J Gastroenterol. 2009 Apr;104(4):920-2. doi: 10.1038/ajg.2009.20. Epub 2009 Mar 17.

Reference Type BACKGROUND
PMID: 19293789 (View on PubMed)

Han JS. Acupuncture and endorphins. Neurosci Lett. 2004 May 6;361(1-3):258-61. doi: 10.1016/j.neulet.2003.12.019.

Reference Type BACKGROUND
PMID: 15135942 (View on PubMed)

Fanti L, Gemma M, Passaretti S, Guslandi M, Testoni PA, Casati A, Torri G. Electroacupuncture analgesia for colonoscopy. a prospective, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):312-6. doi: 10.1111/j.1572-0241.2003.07231.x.

Reference Type BACKGROUND
PMID: 12591047 (View on PubMed)

Robinson R, Darlow S, Wright SJ, Watters C, Carr I, Gadsby G, Mayberry J. Is transcutaneous electrical nerve stimulation an effective analgesia during colonoscopy? Postgrad Med J. 2001 Jul;77(909):445-6. doi: 10.1136/pmj.77.909.445.

Reference Type BACKGROUND
PMID: 11423594 (View on PubMed)

Other Identifiers

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34115/14

Identifier Type: -

Identifier Source: org_study_id

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