Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2007-09-30
2008-03-31
Brief Summary
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Methods: A randomized controlled trial. Healthy volunteers will be randomly allocated to three groups: Acupuncture group - will be submitted to a 20-minute session of acupuncture with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming); Sham group - will be submitted to a 20- minute session of acupuncture with needles inserted in false points located 1 cm from true points in areas without acupuncture's meridians; and Control group - no intervention. IOP measurement by a masked investigator using Goldmann applanation tonometry immediately before the intervention, as well as 30 minutes and 24 hours after the acupuncture.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2
20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians
Sham
20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians
1
20-minute session of acupuncture with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming)
Acupuncture
20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming
3
No interventions assigned to this group
Interventions
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Acupuncture
20-minute session of acupuncture with needles inserted in specific points: Tong Zi Liao, Yang Bai and Jing Ming
Sham
20- minute session of acupuncture with needles inserted in false points allocated 1 cm from the true points in areas without acupuncture's meridians
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* past intraocular surgery
* corneal alterations
* medications that interferes with the intraocular pressure
18 Years
ALL
Yes
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Universidade Federal de São Paulo
Principal Investigators
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Daniel Meira-Freitas, MD
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal de São Paulo
Angelino J Cariello, MD
Role: STUDY_CHAIR
Universidade Federal de São Paulo
Luiz Alberto S Melo Jr., MD
Role: STUDY_DIRECTOR
Universidade Federal de São Paulo
Locations
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Departamento de Oftalmologia - UNIFESP
São Paulo, São Paulo, Brazil
Countries
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References
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Meira-Freitas D, Cariello AJ, Vita RC, Tabosa A, Melo LA Jr. Short-term effect of acupuncture on intraocular pressure in healthy subjects. Acupunct Med. 2010 Mar;28(1):25-7. doi: 10.1136/aim.2009.001081.
Other Identifiers
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CEP 1196/07
Identifier Type: -
Identifier Source: org_study_id
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