Electroacupuncture and Trancutaneous Electrical Nervous Stimulation (TENS) for Colonoscopy Analgesia

Study Overview
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Brief Summary
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To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation (TENS) in reducing patient's discomfort during colonoscopy

Detailed Description
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Evaluation patient's pain and discomfort during colonoscopy, using two non invasive analgesic methods.

Official Title
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Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy: a Prospective, Randomized, Controlled Study

Conditions
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Pain

Intervention / Treatment
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* Other: Acupuncture
* Other: Transcutaneous electrical stimulation
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients scheduled for colonoscopy and in whom deep sedation was not planned will be included in the study Exclusion Criteria: age > 80 and less than 18 years old, severe cardiac or pulmonary disease, anticoagulant, benzodiazepines, antidepressants, opiates therapies, severe cognitive impairment, uncontrolled hypertension.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy | Other: Acupuncture<br>* Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy<br>* Other names: Electroacupuncture;|
| Experimental: transcutaneous electrical stimulation<br>Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy | Other: Transcutaneous electrical stimulation<br>* Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy<br>* Other names: TENS;|
| No Intervention: Control<br>patient are monitored for pain and discomfort | Other: Control<br>* Patients are monitored for pain and discomfort<br>* Other names: No treatment (only sedative drugs if request);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of patients' discomfort and pain during and at the end of colonoscopy both in acupuncture group and in TENS group compare with controls. |  | During colonoscopy, we'll evaluate pain at colorectal, left, trasversal and right colon position of colonscope. At the end of colonoscopy, before discharge, we' ll evaluate patient's general discomfort. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Acupuncture, Transcutaneous electrical nerve stimulation, Colonoscopy