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Acu-TENS for Pain Relief During Colonoscopy

This study is currently recruiting participants.
Verified December 2012 by Chinese University of Hong Kong
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: NA
Last verified: December 2012
History: No changes posted
  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:

U.S. FDA Resources

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%


Estimated Enrollment: 128
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751815

Contacts
Contact: Simon SM Ng, MD (852) 26321495 simonng@surgery.cuhk.edu.hk
Contact: Wing Wa Leung, MSc (852) 26321495 leungww@surgery.cuhk.edu.hk

Locations
China
Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong SAR, China
Contact: Simon SM Ng, MD     (852) 26321495     simonng@surgery.cuhk.edu.hk    
Contact: Wing Wa Leung, MSc     (852) 26321495     leungww@surgery.cuhk.edu.hk    
Principal Investigator: Simon SM Ng, MD            
Sub-Investigator: Wing Wa Leung, MSc            
Sub-Investigator: Tony WC Mak, MD            
Sub-Investigator: Simon KC Chan, MD            
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: December 14, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

ClinicalTrials.gov processed this record on June 18, 2013