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Trial record 5 of 22 for:    Trigeminal Neuralgia
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Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00866424
First received: January 14, 2009
Last updated: March 19, 2009
Last verified: January 2009
History of Changes
  Purpose

The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces pain and improve the life quality in trigeminal neuralgia patients.


Condition Intervention Phase
Trigeminal Neuralgia
Pain
 Procedure: Hyperbaric oxygen, Mock hyperbaric chamber
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ). [ Time Frame: after HBO treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866424

Locations
China, Shaanxi
Xijing Hospital
Xi'an,, Shaanxi, China, 086
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Chair: Li ze Xiong, MD Xijing Hospital, Fourth Military, Medical Univercity
  More Information

No publications provided

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT00866424     History of Changes
Other Study ID Numbers: 20080327-1
Study First Received: January 14, 2009
Last Updated: March 19, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
trigeminal neuralgia
pain
HBO
VAS
MGPQ

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
 Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on May 19, 2013