Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong SAR, China
NCT Number: NCT01368393
Background:
Colonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA) 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 EA in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.
Design:
Prospective, randomized, double-blind, sham-controlled study.
Subjects:
One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture will be recruited.
Interventions:
Patients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA) before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to stabilize the needles and to blind the patients and endoscopists to the treatment allocation. EA and SA 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: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomized to the experimental group will receive electroacupuncture at acupoints relevant to the treatment of abdominal pain and anxiety, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), and Neiguan (pericardium meridian PC-6). Electric stimulation will be employed to the needles
Sterile blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. "Pseudostimulation" will be given by deliberately connecting the needle to the incorrect output socket of the electroacupuncture device, thus there will be no flow of electric current.
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
Electroacupuncture Analgesia for Colonoscopy: a Prospective, Randomized, Double-blind, Sham-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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