Electrical Stimulation Over Acupuncture Points in Reduction of Rectal Discomfort Distension
Non-invasive Acu-point Stimulation (Acu-TENS) in Reduction of Discomfort Associated With Barostat-induced Rectal Distension - a Randomized Controlled Study
1 other identifier
interventional
40
1 country
1
Brief Summary
Colonoscopy is a stressful and unpleasant procedure especially during the passage of the endoscope through angulations of colon. Electro-acupuncture is one of the alternative to reduce colorectal discomfort. However acupuncture is invasive. This present study explored the effectiveness of a non-invasive treatment modality, Transcutaneous Electrical Nerve Stimulation over Acupuncture points in reduction of colorectal discomfort during barostat-induced rectal distension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 13, 2012
CompletedMarch 20, 2012
March 1, 2012
8 months
March 7, 2012
March 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Pain Thresholds
During each 60-second phase of sustained incremental pressure, the subject was asked to rate their colorectal sensation using an electronic panel attached to a computer during the resting 2 minutes. Ratings were "no perception", "first perception of distension", "urge to defecate", "discomfort or pain" and "extreme pain".
3 minutes
Secondary Outcomes (2)
Beta-endorphins level
0 minutes, 45 minutes, 90 minutes, 120 minutes
Visual Analogue Scale for rectal discomfort
3 minutes
Study Arms (2)
Placebo Acu-TENS
PLACEBO COMPARATORNo Electrical output was coming out from the TENS unit
TENS over acupuncture points
EXPERIMENTALA constant mode of electrical stimulation at 2 pulses per second and pulse width at 200µs for 45 minutes. Intensity was set to just initiate muscle contraction.
Interventions
A mobile small machine for nerve stimulation
Eligibility Criteria
You may qualify if:
- Ages of 18-65 undergoing elective colonoscopy
- Patients with American Society of Anaesthesiologists grading I-II
- Informed consent available
You may not qualify if:
- Previous history of colorectal resection and abdominal surgery
- Patients with irritable bowel syndrome (Rome II classifications)
- Previous experiences of colonoscopy
- American Society of Anaesthesiologists grading III or above
- Renal impairment
- Emergency colonoscopy
- Pregnancy
- Allergy to acupuncture needles or electrode pads
- Refuse to enroll into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wing-Wa LEUNG, MSc
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mr
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 13, 2012
Study Start
September 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
March 20, 2012
Record last verified: 2012-03