Electroacupuncture Analgesia for Colonoscopy
1 other identifier
interventional
180
1 country
1
Brief Summary
The objective of this study is to compare the effectiveness of acupuncture versus Sham acupuncture in reducing patient's discomfort and pain during colonoscopy with a standard sedation protocol. This will be objectively measured by the reduction in the amount of analgesia used as well as the time spent in the recovery room.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2017
CompletedFirst Posted
Study publicly available on registry
March 30, 2017
CompletedStudy Start
First participant enrolled
January 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2020
CompletedFebruary 8, 2019
February 1, 2019
2 years
March 2, 2017
February 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in amount of analgesia
Used dosage of midazolam, in combination with fentanyl
1 day per patient
Secondary Outcomes (3)
Patients and gastroenterologist satisfaction
1 day per patient
Time needed to complete the procedure
1 day per patient
Time spent in the recovery room
1 day per patient
Study Arms (3)
True Acupuncture
EXPERIMENTALSham Acupuncture
SHAM COMPARATORControl Group
NO INTERVENTIONInterventions
Acupuncture is a form of alternative medicine and is used worldwide for different indications, mainly for pain management. It relies on the stimulation of specific acupuncture points along the skin of the body using thin needles.
Eligibility Criteria
You may qualify if:
- Subjects undergoing colonoscopy as part of their clinical care
- midazolam/fentanyl sedation
- age above 18 years
- ASA classification I-III,
- Able to give written informed consent
You may not qualify if:
- Age \< 18 years
- ASA classification VI and V
- Allergic reaction to planned medication in the patients' medical history
- Nickel allergy
- Pacemaker/Implanted Cardioverter Device
- Psychiatric and neurologic disorders including epilepsy
- Use of anticoagulants and antiplatelet including aspirin
- Previous colonic resection,
- Patients refusing conscious sedation
- Active GI bleeding
- Patients who had any technical knowledge of acupuncture were also excluded to maintain blindness between acupuncture and sham acupuncture
- Patients with arrhythmia
- Patients with skin disorders in the vicinity of electrodes placement
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
American University of Beirut Medical Center
Beirut, 1103, Lebanon
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 2, 2017
First Posted
March 30, 2017
Study Start
January 9, 2018
Primary Completion
December 30, 2019
Study Completion
February 15, 2020
Last Updated
February 8, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share