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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Hong Kong, China
- Prince of Wales Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo Acu-TENS
No Electrical output was coming out from the TENS unit
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A mobile small machine for nerve stimulation
Andere namen:
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Experimenteel: 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.
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A mobile small machine for nerve stimulation
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Mean Pain Thresholds
Tijdsspanne: 3 minutes
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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".
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3 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Beta-endorphins level
Tijdsspanne: 0 minutes, 45 minutes, 90 minutes, 120 minutes
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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.
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0 minutes, 45 minutes, 90 minutes, 120 minutes
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Visual Analogue Scale for rectal discomfort
Tijdsspanne: 3 minutes
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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".
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3 minutes
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Wing-Wa LEUNG, MSc, Chinese University of Hong Kong
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CRE-2008.546-T
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