deltatrials
Unknown PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT00866424

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

Sponsor: Xijing Hospital

Updated 8 times since 2017 Last updated: Mar 19, 2009 Started: Apr 30, 2008 Primary completion: Jan 31, 2009 Completion: Apr 30, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Pain and Trigeminal Neuralgia and is currently ongoing. Xijing Hospital leads this study, which shows 8 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotEnrolling By Invitation~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown PHASE1/PHASE2

  2. Sep 2025 — Present [monthly]

    Unknown PHASE1/PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE1/PHASE2

    Status: Unknown StatusUnknown · Phase: PHASE1_PHASE2PHASE1/PHASE2

  5. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE1_PHASE2

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE1_PHASE2

  2. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE1_PHASE2

    Status: Enrolling By InvitationUnknown Status

  3. Jan 2017 — Feb 2017 [monthly]

    Enrolling By Invitation PHASE1_PHASE2

    First recorded

Apr 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Xijing Hospital
Data source: Xijing Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations