Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients
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|ClinicalTrials.gov Identifier: NCT00866424|
Recruitment Status : Unknown
Verified January 2009 by Xijing Hospital.
Recruitment status was: Enrolling by invitation
First Posted : March 20, 2009
Last Update Posted : March 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Trigeminal Neuralgia Pain||Procedure: Hyperbaric oxygen, Mock hyperbaric chamber||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Prospective Study on Efficacy of Hyperbaric Oxygenation Treatment for Patients With Trigeminal Neuralgia: a Randomized, Double-Blind, Mock Hyperbaric Chamber -Controlled, Parallel-Group Trial|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||January 2009|
|Estimated Study Completion Date :||April 2009|
|Experimental: A,2, II||
Procedure: Hyperbaric oxygen, Mock hyperbaric chamber
Hyperbaric oxygen treatment for 10 days in treatment groups and mock hyperbaric chamber treatment for 10 days in control groups.
Hyperbaric oxygen treatment: While in the hyperbaric chamber the subjects breathe 100% oxygen saturation with mask at 2.0bars.
Mock hyperbaric chamber treatment: The subjects breathe air freely in the imitation environment chamber at 1.0bars.
Other Name: the delivery of oxygen in a pressurised chamber
- visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ). [ Time Frame: after HBO treatment ]
- visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ),pain frequency, titration of dosage, clinical global impression (CGI) [ Time Frame: at monthly intervals for the subsequent 6 after hyperbaric oxygen (HBO) treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866424
|Xi'an,, Shaanxi, China, 086|
|Study Chair:||Li ze Xiong, MD||Xijing Hospital, Fourth Military, Medical Univercity|