NCT01247935

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 12, 2011

Status Verified

June 1, 2010

Enrollment Period

1 month

First QC Date

November 12, 2010

Last Update Submit

July 11, 2011

Conditions

Pain

Keywords

PainAcupunctureTranscutaneous electrical nerve stimulationColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of patients' discomfort and pain during and at the end of colonoscopy both in acupuncture group and in TENS group compare with controls.

    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.

Study Arms (3)

Acupuncture

EXPERIMENTAL

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

Other: Acupuncture

transcutaneous electrical stimulation

EXPERIMENTAL

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

Other: Transcutaneous electrical stimulation

Control

NO INTERVENTION

patient are monitored for pain and discomfort

Other: Control

Interventions

AcupunctureOTHER

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

Also known as: Electroacupuncture
Acupuncture
Transcutaneous electrical stimulationOTHER

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

Also known as: TENS
transcutaneous electrical stimulation
ControlOTHER

Patients are monitored for pain and discomfort

Also known as: No treatment (only sedative drugs if request)
Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Presidio Ospedaliero di Gorizia

Gorizia, 34170, Italy

Location

Related Publications (5)

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

    PMID: 12377792BACKGROUND

  • 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.

    PMID: 19293789BACKGROUND

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

    PMID: 15135942BACKGROUND

  • 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.

    PMID: 12591047BACKGROUND

  • 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.

    PMID: 11423594BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Acupuncture TherapyElectroacupunctureTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Corrado Thomann, MD

    ICU Gorizia Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 25, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

July 12, 2011

Record last verified: 2010-06

Locations

IT(1)