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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
Sponsor:
Information provided by:
Xijing Hospital

January 14, 2009
March 20, 2009
March 20, 2009
April 2008
January 2009   (Final data collection date for primary outcome measure)
visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ). [ Time Frame: after HBO treatment ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients
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
The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces pain and improve the life quality in trigeminal neuralgia patients.
Trigeminal neuralgia(TN) is a recurrent severe shooting neuropathic pain. Treatment of this pain continues to be a challenge in clinical pain management. Hyperbaric oxygen (HBO) has been used of neuropathic diseases, which can improve blood partial pressure of oxygen, reduce edema, relieve neural oppression and attenuate inflammatory response. The hypothesis of this protocol is that hyperbaric oxygen treatment could relieve neuropathic pain and improve the quality of life in TN patients. Visual analogue scale (VAS) and the mcgill pain questionnaire (MGPQ) will be assessed before the initiation of the study, after hyperbaric oxygen (HBO) treatment and at monthly intervals for the subsequent 3 months. Titration of dosage and pain frequency will be recorded throughout the study. Clinical global impression (CGI) by the individual patient will be evaluated at monthly intervals after HBO treatment.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Trigeminal Neuralgia
  • Pain
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
Experimental: A,2, II
Intervention: Procedure: Hyperbaric oxygen, Mock hyperbaric chamber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
Same as current
April 2009
January 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18-70
  2. Primary TN patient (MRI examination support diagnosis)
  3. Suffering from this pain for at least 3 months
  4. VAS﹥40mm
  5. Patient can assess pain intensity correctly

Exclusion Criteria:

  1. Undergone surgery for TN(including nerve injections) within the last year
  2. Oral medicine change within the last week
  3. With other diseases of nervous system
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00866424
20080327-1
Yes
Not Provided
Not Provided
Lize Xiong/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, Fourth Military Medical University
Xijing Hospital
Not Provided
Study Chair: Li ze Xiong, MD Xijing Hospital, Fourth Military, Medical Univercity
Xijing Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP