NCT02077270

Brief Summary

The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 24, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

February 24, 2014

Last Update Submit

November 16, 2015

Conditions

Pain

Keywords

colonoscopyacupuncturepain

Outcome Measures

Primary Outcomes (1)

  • Efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy by measuring sedative drug amounts during colonoscopy

    The measurement of the amount of drug added during colonoscopy

    during the colonoscopy and in the hour post procedure

Secondary Outcomes (4)

  • Time of insertion till the cecum.

    during colonoscopy

  • Time of post-colonoscopy recovery as measured by the Aldrete score

    up to 1 hour post colonoscopy

  • Number of intra-examination adverse events.

    from the begining of the endoscopy and up to 1 hour post procedure

  • Patient's total satisfaction with the exam and the analgesia

    between the end of the procedure and up to 1 hour post procedure

Study Arms (3)

electroacupuncture

EXPERIMENTAL

patients in whom precolonoscopic electroacupuncture is preformed

Procedure: electroacupuncture

Sham electroacupuncture

PLACEBO COMPARATOR

sham electroacupuncture

Procedure: electroacupuncture

No intervantion

SHAM COMPARATOR

no intervantion

Procedure: electroacupuncture

Interventions

electroacupuncturePROCEDURE

Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),

No intervantionSham electroacupunctureelectroacupuncture

Eligibility Criteria

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

You may qualify if:

  • Adult Patients referred for their first colonoscopy in the department of GI in Sheba, Tel Hashomer

You may not qualify if:

  • Ages \<18y \>75y
  • Any prior gastrointestinal endoscopy.
  • History of colonic resection.
  • Known or suspected stenosis of the colon.
  • Pregnancy.
  • Inflammatory bowel disease
  • Neuropsychiatric disorders or receiving psychotropic drugs.
  • Prior knowledge or experience of acupuncture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 53261, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Central Study Contacts

Dan Carter, MD

CONTACT

97235302197dan.carter@sheba.health.gov.il

Eytan Bardan, MD

CONTACT

97235303130bardan@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GI consult

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 4, 2014

Study Start

January 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

IL(1)