Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong SAR, China
NCT Number: NCT01751815
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 3
Hong Kong SAR, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Patients randomized to the control group will receive placebo-TENS at the same acupoints.
Time frame: During the procedure (up to 1 day)
Time frame: During the procedure (up to 1 day)
Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful
Time frame: During the procedure (up to 1 day)
Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied
Time frame: Up to 1 day
Time frame: During the procedure (up to 1 day)
Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied
Time frame: During the procedure (up to 1 day)
Complete colonoscopy is defined as identification of ileocecal valve
Time frame: During the procedure (up to 1 day)
The time from introduction of the colonoscope to the cecum
Time frame: During the procedure (up to 1 day)
Time frame: During the procedure (up to 1 day)
Defined as systolic blood pressure <90 mmHg
Time frame: During the procedure (up to 1 day)
Defined as SaO2 <90%
Chinese University of Hong Kong
Other
The Application of Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for Pain Relief During Colonoscopy: a Prospective, Randomized, Placebo-controlled Study
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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