Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

NCT ID: NCT00866424

Last Updated: 2009-03-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Trigeminal Neuralgia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A,2, II

Group Type EXPERIMENTAL

Hyperbaric oxygen, Mock hyperbaric chamber

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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the delivery of oxygen in a pressurised chamber

Eligibility Criteria

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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. VASīšĨ40mm
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fourth Military Medical University

Principal Investigators

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Li ze Xiong, MD

Role: STUDY_CHAIR

Xijing Hospital, Fourth Military, Medical Univercity

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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20080327-1

Identifier Type: -

Identifier Source: org_study_id

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