Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients

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

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

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.

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