Acu-TENS for Pain Relief During Colonoscopy

Pain Clinical Trial

Official title:

The Application of Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for Pain Relief During Colonoscopy: a Prospective, Randomized, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751815
• Other study ID #: CRE-2011.442-T
• Status: Completed
• Phase: Phase 3
• First received: December 14, 2012
• Last updated: February 10, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Background:

Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy.

Objective:

To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.

Design:

Prospective, randomized, placebo-controlled study.

Subjects:

One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.

Interventions:

Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension, including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS group, a non-conductive plastic film will be placed between the acupoint and the electrode so that no current will be transmitted. Acu-TENS and placebo-TENS will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups.

Outcome measures:

Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy

• Patients with American Society of Anesthesiologists (ASA) grading I-II

• Informed consent available

Exclusion Criteria:

• Patients with previous experience of acupuncture or Acu-TENS

• Patients with previous history of colorectal surgery

• Patients who are diagnosed with irritable bowel syndrome according to Rome III criteria

• Patients with chronic pain syndrome

• Patients with psychiatric disorder

• Patients with poor cognitive function

• Patients with renal impairment

• Patients with obstructive sleep apnea syndrome

• Patients with cardiac arrhythmias

• Patients with cardiac pacemaker

• Patients who are pregnant

• Patients who are allergic to the Acu-TENS electrodes or Propofol/Alfentanil

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Acu-TENS
Patients randomized to the experimental group will receive Acu-TENS on acupoints relevant to the treatment of abdominal pain and distension, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), Neiguan (pericardium meridian PC-6), Tianshu (stomach meridian ST-25), and Dachangshu (bladder meridian BL-25).
• Placebo-TENS
Patients randomized to the control group will receive placebo-TENS at the same acupoints.

Locations

Country	Name	City	State
China	Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of patient-controlled sedation/analgesia consumed		During the procedure (up to 1 day)	No
Secondary	Pain score	Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful	During the procedure (up to 1 day)	No
Secondary	Patients' satisfaction score	Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied	During the procedure (up to 1 day)	No
Secondary	Patients' willingness to repeat the procedure		Up to 1 day	No
Secondary	Endoscopists' satisfaction score	Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied	During the procedure (up to 1 day)	No
Secondary	Cecal intubation rate	Complete colonoscopy is defined as identification of ileocecal valve	During the procedure (up to 1 day)	No
Secondary	Cecal intubation time	The time from introduction of the colonoscope to the cecum	During the procedure (up to 1 day)	No
Secondary	Total procedure time		During the procedure (up to 1 day)	No
Secondary	Episodes of hypotension	Defined as systolic blood pressure <90 mmHg	During the procedure (up to 1 day)	Yes
Secondary	Episodes of desaturation	Defined as SaO2 <90%	During the procedure (up to 1 day)	Yes