Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

A

Air Force Military Medical University of People's Liberation Army

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Trigeminal Neuralgia
Pain

Treatments

Procedure: Hyperbaric oxygen, Mock hyperbaric chamber

Study type

Interventional

Funder types

Other

Identifiers

NCT00866424
20080327-1

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 1 patient group

A,2, II
Experimental group
Treatment:
Procedure: Hyperbaric oxygen, Mock hyperbaric chamber

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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