Acu-TENS for Pain Relief During Colonoscopy

Phase 3

Completed

• Conditions: Pain
• Interventions: Procedure: Acu-TENS; Procedure: Placebo-TENS

• Registration Number: NCT01751815
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-18
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acu-TENS	Acu-TENS	-
Placebo-TENS	Placebo-TENS	-

Primary Outcome Measures

Name	Time	Method
Dose of patient-controlled sedation/analgesia consumed	During the procedure (up to 1 day)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇨🇳 Hong Kong SAR, China