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| Sponsored by: |
Xijing Hospital |
|---|---|
| Information provided by: | Xijing Hospital |
| ClinicalTrials.gov Identifier: | NCT00866424 |
Purpose
The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces pain and improve the life quality in trigeminal neuralgia patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Trigeminal Neuralgia Pain |
Procedure: Hyperbaric oxygen, Mock hyperbaric chamber |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A,2, II: Experimental |
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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Fourth Military Medical University ( Lize Xiong/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 ID Numbers: | 20080327-1 |
| Study First Received: | January 14, 2009 |
| Last Updated: | March 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00866424 History of Changes |
| Health Authority: | China: State Food and Drug Administration |
|
trigeminal neuralgia pain HBO VAS MGPQ |
|
Signs and Symptoms Neuromuscular Diseases Neuralgia Peripheral Nervous System Diseases |
Neurologic Manifestations Pain Trigeminal Neuralgia |
|
Signs and Symptoms Neuromuscular Diseases Neuralgia Peripheral Nervous System Diseases Nervous System Diseases |
Neurologic Manifestations Trigeminal Nerve Diseases Pain Cranial Nerve Diseases Trigeminal Neuralgia |
