Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients
|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 ]
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|