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Electrical Stimulation Over Acupuncture Points in Reduction of Rectal Discomfort Distension

19. März 2012 aktualisiert von: Wing-Wa Leung, MSc, Chinese University of Hong Kong

Non-invasive Acu-point Stimulation (Acu-TENS) in Reduction of Discomfort Associated With Barostat-induced Rectal Distension - a Randomized Controlled Study

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Hong Kong, China
        • Prince of Wales Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo Acu-TENS
No Electrical output was coming out from the TENS unit
A mobile small machine for nerve stimulation
Andere Namen:
  • (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.
A mobile small machine for nerve stimulation
Andere Namen:
  • (Model 120Z, ITO Company Limited, Tokyo, Japan)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Pain Thresholds
Zeitfenster: 3 minutes
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Beta-endorphins level
Zeitfenster: 0 minutes, 45 minutes, 90 minutes, 120 minutes
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.
0 minutes, 45 minutes, 90 minutes, 120 minutes
Visual Analogue Scale for rectal discomfort
Zeitfenster: 3 minutes
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".
3 minutes

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Wing-Wa LEUNG, MSc, Chinese University of Hong Kong

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2009

Primärer Abschluss (Tatsächlich)

1. Mai 2010

Studienabschluss (Tatsächlich)

1. Mai 2010

Studienanmeldedaten

Zuerst eingereicht

7. März 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. März 2012

Zuerst gepostet (Schätzen)

13. März 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

20. März 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. März 2012

Zuletzt verifiziert

1. März 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CRE-2008.546-T

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