Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

Study Overview
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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.

Official Title
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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

Conditions
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Trigeminal Neuralgia, Pain

Intervention / Treatment
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* Procedure: Hyperbaric oxygen, Mock hyperbaric chamber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 Primary TN patient (MRI examination support diagnosis) Suffering from this pain for at least 3 months VAS﹥40mm Patient can assess pain intensity correctly Exclusion Criteria: Undergone surgery for TN(including nerve injections) within the last year Oral medicine change within the last week With other diseases of nervous system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,2, II<br> | Procedure: Hyperbaric oxygen, Mock hyperbaric chamber<br>* 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.<br>* Other names: the delivery of oxygen in a pressurised chamber;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ). |  | after HBO treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ),pain frequency, titration of dosage, clinical global impression (CGI) |  | at monthly intervals for the subsequent 6 after hyperbaric oxygen (HBO) treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trigeminal neuralgia, pain, HBO, VAS, MGPQ