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Electrical Stimulation Over Acupuncture Points in Reduction of Rectal Discomfort Distension

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation (ITO Company )
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Colonoscopy, TENS, Acupuncture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Ages of 18-65 undergoing elective colonoscopy
  2. Patients with American Society of Anaesthesiologists grading I-II
  3. Informed consent available

Exclusion Criteria:

  1. Previous history of colorectal resection and abdominal surgery
  2. Patients with irritable bowel syndrome (Rome II classifications)
  3. Previous experiences of colonoscopy
  4. American Society of Anaesthesiologists grading III or above
  5. Renal impairment
  6. Emergency colonoscopy
  7. Pregnancy
  8. Allergy to acupuncture needles or electrode pads
  9. Refuse to enroll into the study

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Acu-TENS

TENS over acupuncture points

Arm Description

No Electrical output was coming out from the TENS unit

A 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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Beta-endorphins level
Venous blood (3 mL) was drawn (from a cannula inserted into the cubital vein of each subject under aseptic technique) before the randomization process (0 minute), immediately after the 45 minutes intervention (45 minutes), at a distension pressure of 24mmHg (45 minutes) and at the end of the intervention (120 minutes). The blood samples were transferred to EDTA tubes with a 4 ºC ice box to the biochemistry laboratory and centrifuged for further assayed with ELISA kit.
Visual Analogue Scale for rectal discomfort
Each subject was also asked to rate the degree of rectal discomfort using a visual analogue scale (VAS) with a 10cm un-graduated line, with words "no discomfort at all" anchored to "0" end and "discomfort cannot be tolerated" anchored to the number "10".

Full Information

First Posted
March 7, 2012
Last Updated
March 19, 2012
Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT01551654
Brief Title
Electrical Stimulation Over Acupuncture Points in Reduction of Rectal Discomfort Distension
Official Title
Non-invasive Acu-point Stimulation (Acu-TENS) in Reduction of Discomfort Associated With Barostat-induced Rectal Distension - a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Early colonoscopy screening is encouraged in prevention of development of colorectal cancer as the colonoscopy procedure allows removal of pathological polyps and reduces the risk of cancerous development. While colonoscopy is regarded a minimally invasive procedure, the procedure itself is often associated with abdominal pain and discomfort, especially when the colonoscope is passed through a colonic angulation. The unpleasant feeling during colonoscopy may affect the patient's overall tolerance to the procedure and thereby jeopardizing the accuracy of outcome findings. A combination of narcotic analgesia and benzodiazepines is often used to decrease the abdominal pain and colorectal discomfort during colonoscopy. However these medications are also associated with side effects such as nausea and vomiting. Although uncommon, respiratory and cardiac arrests during colonoscopy were reported. Colonoscopy is now an outpatient day-procedure, unwanted side effects however could prolong recovery time and increase demands of post-intervention nursing care, thereby affecting the cost-effectiveness of the medical model. Undesirable pharmacological side effects have recently led to exploration of alternative management strategies to minimize patient discomfort during colonoscopy. Electroacupuncture (EA) is widely accepted in China and is considered worldwide a possible treatment option for acute and chronic pain of various origins. The role of acupuncture in managing pain and anxiety during colonoscopy however is unclear. A randomized sham-controlled study (involving 30 patients) suggested that patients receiving EA to acupoints including Zusanli (stomach meridian ST-36) and Hegu (large intestine meridian LI-4) had lower pain level during colonoscopy than those receiving sham acupuncture (SA), but the difference was non-significant statistically. Recently the investigators have shown that application of 45 minutes of EA to Hegu (LI4), Neiguan (PC6) and Zusanli (ST36) was able to effectively reduce colorectal discomfort during Barostat-induced rectal distension. Acupuncture however is invasive, and its application requires an experienced acupuncturist. Application of Transcutaneous electrical nerve stimulation (TENS) over acupuncture points (Acu-TENS) is a non-invasive modality and a novel analgesic therapy that combines the advantages of acupuncture and TENS in management of painful conditions. Acu-TENS has been shown to be more effective in reducing postoperative analgesic requirement when compared with TENS at nonacupoints. It is postulated that TENS possibly modulates the noxious stimulus of pain via the control of the 'pain-gate' or through the release of β-endorphin. The efficacy of Acu-TENS in pain-relief during colonoscopy has not been reported. This current study aims to investigate the effect of Acu-TENS on barostat-induced rectal discomfort. A dual drive barostat device was used to mimic colonoscopy in order to control for the nature, intensity and duration of isobaric distension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain, Colonoscopy, TENS, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Acu-TENS
Arm Type
Placebo Comparator
Arm Description
No Electrical output was coming out from the TENS unit
Arm Title
TENS over acupuncture points
Arm Type
Experimental
Arm Description
A 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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (ITO Company )
Other Intervention Name(s)
(Model 120Z, ITO Company Limited, Tokyo, Japan)
Intervention Description
A mobile small machine for nerve stimulation
Primary Outcome Measure Information:
Title
Mean Pain Thresholds
Description
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".
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Beta-endorphins level
Description
Venous blood (3 mL) was drawn (from a cannula inserted into the cubital vein of each subject under aseptic technique) before the randomization process (0 minute), immediately after the 45 minutes intervention (45 minutes), at a distension pressure of 24mmHg (45 minutes) and at the end of the intervention (120 minutes). The blood samples were transferred to EDTA tubes with a 4 ºC ice box to the biochemistry laboratory and centrifuged for further assayed with ELISA kit.
Time Frame
0 minutes, 45 minutes, 90 minutes, 120 minutes
Title
Visual Analogue Scale for rectal discomfort
Description
Each subject was also asked to rate the degree of rectal discomfort using a visual analogue scale (VAS) with a 10cm un-graduated line, with words "no discomfort at all" anchored to "0" end and "discomfort cannot be tolerated" anchored to the number "10".
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages of 18-65 undergoing elective colonoscopy Patients with American Society of Anaesthesiologists grading I-II Informed consent available Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing-Wa LEUNG, MSc
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Electrical Stimulation Over Acupuncture Points in Reduction of Rectal Discomfort Distension

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