Acu-TENS for Pain Relief During Colonoscopy
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About
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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
135 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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