Acu-TENS for Pain Relief During Colonoscopy
|ClinicalTrials.gov Identifier: NCT01751815|
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : February 11, 2014
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.
To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.
Prospective, randomized, placebo-controlled study.
One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.
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.
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 or disease||Intervention/treatment||Phase|
|Pain||Procedure: Acu-TENS Procedure: Placebo-TENS||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Application of Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for Pain Relief During Colonoscopy: a Prospective, Randomized, Placebo-controlled Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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||
Patients randomized to the control group will receive placebo-TENS at the same acupoints.
- Dose of patient-controlled sedation/analgesia consumed [ Time Frame: During the procedure (up to 1 day) ]
- 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
- 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
- Patients' willingness to repeat the procedure [ Time Frame: Up to 1 day ]
- 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
- Cecal intubation rate [ Time Frame: During the procedure (up to 1 day) ]Complete colonoscopy is defined as identification of ileocecal valve
- Cecal intubation time [ Time Frame: During the procedure (up to 1 day) ]The time from introduction of the colonoscope to the cecum
- Total procedure time [ Time Frame: During the procedure (up to 1 day) ]
- Episodes of hypotension [ Time Frame: During the procedure (up to 1 day) ]Defined as systolic blood pressure <90 mmHg
- Episodes of desaturation [ Time Frame: During the procedure (up to 1 day) ]Defined as SaO2 <90%
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751815
|Prince of Wales Hospital, The Chinese University of Hong Kong|
|Hong Kong SAR, China|
|Principal Investigator:||Simon SM Ng, MD||Chinese University of Hong Kong|