Pretreatment With Electroacupuncture to Reduce Discomfort

Pain Clinical Trial

Official title:

Pretreatment With Electroacupuncture to Reduce Discomfort

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02077270
• Other study ID #: SHEBA-14-9733-DC-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: November 16, 2015
• Start date: January 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2015
• Source: Sheba Medical Center
• Contact: Dan Carter, MD
• Phone: 97235302197
• Email: dan.carter[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Description:

To assess the efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Ages <18y >75y

2. Any prior gastrointestinal endoscopy.

3. History of colonic resection.

4. Known or suspected stenosis of the colon.

5. Pregnancy.

6. Inflammatory bowel disease

7. Neuropsychiatric disorders or receiving psychotropic drugs.

8. Prior knowledge or experience of acupuncture.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• electroacupuncture
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),

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time of insertion till the cecum.	Time between insertion of the colonoscopy and the image of the cecum	during colonoscopy	No
Secondary	Time of post-colonoscopy recovery as measured by the Aldrete score		up to 1 hour post colonoscopy	No
Secondary	Number of intra-examination adverse events.		from the begining of the endoscopy and up to 1 hour post procedure	Yes
Secondary	Patient's total satisfaction with the exam and the analgesia		between the end of the procedure and up to 1 hour post procedure	No