Acu-TENS for Pain Relief During Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: Acu-TENS; Procedure: Placebo-TENS

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China
    • Prince of Wales Hospital, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acu-TENS	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).
Sham Comparator: Placebo-TENS	Procedure: Placebo-TENS; Patients randomized to the control group will receive placebo-TENS at the same acupoints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose of patient-controlled sedation/analgesia consumed	During the procedure (up to 1 day)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Estimate): February 11, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CRE-2011.442-T