Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

Phase 1

• Conditions: Trigeminal Neuralgia; Pain
• Interventions: Procedure: Hyperbaric oxygen, Mock hyperbaric chamber

• Registration Number: NCT00866424
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-04
• Status Verified: 2009-01
• Primary Completion: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-03-19
• Last Update Submitted: 2009-03-19
• Study First Posted: 2009-03-20
• Last Update Posted: 2009-03-20
• Study Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,2, II	Hyperbaric oxygen, Mock hyperbaric chamber	-

Primary Outcome Measures

Name	Time	Method
visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ).	after HBO treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an,, Shaanxi, China