Back to results

Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

Primary Purpose

Trigeminal Neuralgia, Pain

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Hyperbaric oxygen, Mock hyperbaric chamber

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring trigeminal neuralgia, pain, HBO, VAS, MGPQ

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xijing Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A,2, II

Arm Description

Outcomes

Primary Outcome Measures

visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ).

Secondary Outcome Measures

visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ),pain frequency, titration of dosage, clinical global impression (CGI)

Full Information

NCT ID

NCT00866424

First Posted

January 14, 2009

Last Updated

March 19, 2009

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00866424

Brief Title

Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

January 2009 (Anticipated)

Study Completion Date

April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigeminal Neuralgia, Pain

Keywords

trigeminal neuralgia, pain, HBO, VAS, MGPQ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A,2, II

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Hyperbaric oxygen, Mock hyperbaric chamber

Other Intervention Name(s)

the delivery of oxygen in a pressurised chamber

Intervention Description

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.

Primary Outcome Measure Information:

Title

visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ).

Time Frame

after HBO treatment

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li ze Xiong, MD

Organizational Affiliation

Xijing Hospital, Fourth Military, Medical Univercity

Official's Role

Study Chair

Facility Information:

Facility Name

Xijing Hospital

City

Xi'an,

State/Province

Shaanxi

ZIP/Postal Code

086

Country

China

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

We'll reach out to this number within 24 hrs