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Electrical Stimulation Over Acupuncture Points in Reduction of Rectal Discomfort Distension

This study has been completed.
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Wing-Wa Leung, MSc, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01551654
First received: March 7, 2012
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Pain
Device: Transcutaneous Electrical Nerve Stimulation (ITO Company )

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-invasive Acu-point Stimulation (Acu-TENS) in Reduction of Discomfort Associated With Barostat-induced Rectal Distension - a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Mean Pain Thresholds [ Time Frame: 3 minutes ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0 minutes, 45 minutes, 90 minutes, 120 minutes ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 minutes ] [ Designated as safety issue: Yes ]
    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".


Enrollment: 40
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Acu-TENS
No Electrical output was coming out from the TENS unit
Device: Transcutaneous Electrical Nerve Stimulation (ITO Company )
A mobile small machine for nerve stimulation
Other Name: (Model 120Z, ITO Company Limited, Tokyo, Japan)
Experimental: TENS over acupuncture points
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.
Device: Transcutaneous Electrical Nerve Stimulation (ITO Company )
A mobile small machine for nerve stimulation
Other Name: (Model 120Z, ITO Company Limited, Tokyo, Japan)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551654

Locations
China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Wing-Wa LEUNG, MSc Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Wing-Wa Leung, MSc, Mr, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01551654     History of Changes
Other Study ID Numbers: CRE-2008.546-T
Study First Received: March 7, 2012
Last Updated: March 19, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Pain
Colonoscopy
TENS
Acupuncture

ClinicalTrials.gov processed this record on November 27, 2014