Acu-TENS for Pain Relief During Colonoscopy

NCT01751815 | Completed Phase 3

• 1 other identifier: CRE-2011.442-T
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Dose of patient-controlled sedation/analgesia consumed

  During the procedure (up to 1 day)

Secondary Outcomes (9)

• Pain score

  During the procedure (up to 1 day)

• Patients' satisfaction score

  During the procedure (up to 1 day)

• Patients' willingness to repeat the procedure

  Up to 1 day

• Endoscopists' satisfaction score

  During the procedure (up to 1 day)

• Cecal intubation rate

  During the procedure (up to 1 day)

Study Arms (2)

Acu-TENS

EXPERIMENTAL

Procedure: Acu-TENS

Placebo-TENS

SHAM COMPARATOR

Procedure: Placebo-TENS

Interventions

Acu-TENS PROCEDURE

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).

Acu-TENS

Placebo-TENS PROCEDURE

Patients randomized to the control group will receive placebo-TENS at the same acupoints.

Placebo-TENS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon SM Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

CN (1)