NCT00866424

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 20, 2009

Status Verified

January 1, 2009

Enrollment Period

9 months

First QC Date

January 14, 2009

Last Update Submit

March 19, 2009

Conditions

Trigeminal NeuralgiaPain

Keywords

trigeminal neuralgiapainHBOVASMGPQ

Outcome Measures

Primary Outcomes (1)

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

    after HBO treatment

Secondary Outcomes (1)

  • 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

Study Arms (1)

A,2, II

EXPERIMENTAL
Procedure: Hyperbaric oxygen, Mock hyperbaric chamber

Interventions

Hyperbaric oxygen, Mock hyperbaric chamberPROCEDURE

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.

Also known as: the delivery of oxygen in a pressurised chamber
A,2, II

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Undergone surgery for TN(including nerve injections) within the last year
  • Oral medicine change within the last week
  • With other diseases of nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 086, China

Location

MeSH Terms

Conditions

Trigeminal NeuralgiaPain

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Li ze Xiong, MD

    Xijing Hospital, Fourth Military, Medical Univercity

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2009

First Posted

March 20, 2009

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

March 20, 2009

Record last verified: 2009-01

Locations

CN(1)