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Completed

NCT Number: NCT01751815

Acu-TENS for Pain Relief During Colonoscopy

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong SAR, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Placebo-TENS

Procedure

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

Primary outcomes

  1. Dose of patient-controlled sedation/analgesia consumed

    Time frame: During the procedure (up to 1 day)

Secondary outcomes

  1. Pain score

    Time frame: During the procedure (up to 1 day)

    Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful

  2. Patients' satisfaction score

    Time frame: During the procedure (up to 1 day)

    Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied

  3. Patients' willingness to repeat the procedure

    Time frame: Up to 1 day

  4. Endoscopists' satisfaction score

    Time frame: During the procedure (up to 1 day)

    Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied

  5. Cecal intubation rate

    Time frame: During the procedure (up to 1 day)

    Complete colonoscopy is defined as identification of ileocecal valve

  6. Cecal intubation time

    Time frame: During the procedure (up to 1 day)

    The time from introduction of the colonoscope to the cecum

  7. Total procedure time

    Time frame: During the procedure (up to 1 day)

  8. Episodes of hypotension

    Time frame: During the procedure (up to 1 day)

    Defined as systolic blood pressure <90 mmHg

  9. Episodes of desaturation

    Time frame: During the procedure (up to 1 day)

    Defined as SaO2 <90%

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 18, 2012
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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