Clinical trial NCT01751815: Acu-TENS for Pain Relief During Colonoscopy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Dose of patient-controlled sedation/analgesia consumed
timeFrame: During the procedure (up to 1 day)
Secondary outcomes:
measure: Pain score
timeFrame: During the procedure (up to 1 day)
measure: Patients' satisfaction score
timeFrame: During the procedure (up to 1 day)
measure: Patients' willingness to repeat the procedure
timeFrame: Up to 1 day
measure: Endoscopists' satisfaction score
timeFrame: During the procedure (up to 1 day)
measure: Cecal intubation rate
timeFrame: During the procedure (up to 1 day)
measure: Cecal intubation time
timeFrame: During the procedure (up to 1 day)
measure: Total procedure time
timeFrame: During the procedure (up to 1 day)
measure: Episodes of hypotension
timeFrame: During the procedure (up to 1 day)
measure: Episodes of desaturation
timeFrame: During the procedure (up to 1 day)
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon SM Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: