Trigeminal NeuralgiaPhase 1/2NCT00866424
Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients
A Phase 1/2 study testing Hyperbaric oxygen, Mock hyperbaric chamber in people with Trigeminal Neuralgia and Pain, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces pain and improve the life quality in trigeminal neuralgia patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Trigeminal Neuralgia, Pain
- What is being tested?
- Hyperbaric oxygen, Mock hyperbaric chamber
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to Apr 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Primary TN patient (MRI examination support diagnosis)
- Suffering from this pain for at least 3 months
- VAS﹥40mm
- Patient can assess pain intensity correctly
Who cannot join
- Undergone surgery for TN(including nerve injections) within the last year
- Oral medicine change within the last week
- With other diseases of nervous system
Trial locations and contacts
1 site in 1 country.
About this 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
The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces pain and improve the life quality in trigeminal neuralgia patients.
Read the detailed 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.
- Conditions
- Trigeminal Neuralgia, Pain
- Being tested
- Hyperbaric oxygen, Mock hyperbaric chamber
- Keywords
- trigeminal neuralgia, pain, HBO, VAS, MGPQ
- Medical subject headings
- Trigeminal Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen, Mock hyperbaric chamberProcedure or surgery
Also called the delivery of oxygen in a pressurised 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.
| Study group | Role | What they receive |
|---|---|---|
| A,2, II | Experimental | Not described Receives: Procedure: Hyperbaric oxygen, Mock hyperbaric chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ).
Measured: after HBO treatment
Secondary outcomes (1)
visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ),pain frequency, titration of dosage, clinical global impression (CGI)
Measured: at monthly intervals for the subsequent 6 after hyperbaric oxygen (HBO) treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startApr 2008
- Primary completionJan 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Li ze Xiong, MD, Study chair, Xijing Hospital, Fourth Military, Medical Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866424
- Sponsor's protocol ID
- 20080327-1
- Status last verified
- Jan 2009
- First submitted
- 14 Jan 2009
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00866424
- Acronym / sponsor ID
- 20080327-1
- Conditions
- Trigeminal Neuralgia, Pain
- Keywords
- trigeminal neuralgia, pain, HBO, VAS, MGPQ
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the hyperbaric oxygen treatment reduces pain and improve the life quality in trigeminal neuralgia patients.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A,2, II | Experimental | Procedure: Hyperbaric oxygen, Mock hyperbaric chamber |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70
- Primary TN patient (MRI examination support diagnosis)
- Suffering from this pain for at least 3 months
- VAS﹥40mm
- Patient can assess pain intensity correctly
Key exclusion criteria (3 listed)
- Undergone surgery for TN(including nerve injections) within the last year
- Oral medicine change within the last week
- With other diseases of nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen, Mock hyperbaric chamberAlso: the delivery of oxygen in a pressurised chamberHyperbaric 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. | Procedure or surgery | A,2, II |
Primary outcome
visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ).
Time frame: after HBO treatment
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li ze Xiong, MD study chair
Xijing Hospital, Fourth Military, Medical Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyperbaric oxygen, Mock hyperbaric chamber in people with Trigeminal Neuralgia and Pain, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ). (time frame: after HBO treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2009.