A Phase 1/2 interventional study of Hyperbaric oxygen, Mock hyperbaric chamber in Trigeminal Neuralgia and Pain, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-03-20.
Sponsored by Xijing Hospital · Phase 1/2, Interventional, and Treatment
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.
135 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 92 interventional studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
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Exclusion Criteria:
Procedure: Hyperbaric oxygen, Mock hyperbaric chamber
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
visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ).
Time frame: after HBO treatment
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
This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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Xijing Hospital