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Acu-TENS for Pain Relief During Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simon S. M. Ng, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01751815
First received: December 14, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Pain
Procedure: Acu-TENS
Procedure: Placebo-TENS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Application of Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for Pain Relief During Colonoscopy: a Prospective, Randomized, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Dose of patient-controlled sedation/analgesia consumed [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain score [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful

  • Patients' satisfaction score [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied

  • Patients' willingness to repeat the procedure [ Time Frame: Up to 1 day ] [ Designated as safety issue: No ]
  • Endoscopists' satisfaction score [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied

  • Cecal intubation rate [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    Complete colonoscopy is defined as identification of ileocecal valve

  • Cecal intubation time [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
    The time from introduction of the colonoscope to the cecum

  • Total procedure time [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: No ]
  • Episodes of hypotension [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: Yes ]
    Defined as systolic blood pressure <90 mmHg

  • Episodes of desaturation [ Time Frame: During the procedure (up to 1 day) ] [ Designated as safety issue: Yes ]
    Defined as SaO2 <90%


Enrollment: 135
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751815

Locations
China
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Simon SM Ng, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Simon S. M. Ng, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01751815     History of Changes
Other Study ID Numbers: CRE-2011.442-T
Study First Received: December 14, 2012
Last Updated: February 10, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

ClinicalTrials.gov processed this record on November 25, 2014