Migraine DisordersPhase 4NCT06432127
Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis
A Phase 4 study testing Bupivacaine in people with Migraine Disorders, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this randomized controlled study in Thailand. is to find if there is a role of local anesthetic greater occipital nerve block at Cervical spine level 2 under ultrasound guide in prophylaxis of episodic migraine and chronic migraine in patients with failed oral prophylaxis medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteThailand
- Study dates
- 30 May 2024to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 -65 years old
- Diagnosis as episodic migraine or chronic migraine and had indication to use migraine prophylaxis
- Volunteer prefer to use research procedure as first choice of migraine prophylaxis
- Volunteer already had migraine prophylaxis treatment but still has the one of these following problem 4.1 Frequency of migraine attack more than 4 times/month 4.2 Severe migraine headache \& disturb daily life in spite of using migraine prophylaxis 4.3 Having migraine medication side effect, either from prophylaxis or acute attack medication and cannot titration medication dosage 4.4 migraine attack not improved as using many migraine prophylaxis medications 4.5 Having contra-indication to use prophylaxis migraine medication or standard prophylaxis procedure such as botulinum toxin 4.6 Cannot take prophylaxis medication daily (low compliance) 4.7 Had financial problems in using standard prophylaxis migraine medication or procedure 4.8 Medication overuse headache
Who cannot join
- Had these type of headache in combination with migraine
- cervicogenic headache
- occipital neuralgia
- secondary headache
- Had contraindication on greater occipital nerve block injection at cervical spine level 2 under ultrasound-guided such as skin infection in needle site
- Allergy to local anesthetic
- Uncontrolled psychiatric disorder in 3 months before attending research
- Cannot understand or reading, writing Thai language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Raviwon Atisook
Bangkok, 10700
Raviwon Atisook, M.D, +66819140784, raviwon.ati@gmail.com
About this study
Official title: Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis in Patients With Failed Oral Prophylaxis Medication : A Randomized Controlled Study in Thailand
The goal of this randomized controlled study in Thailand. is to find if there is a role of local anesthetic greater occipital nerve block at Cervical spine level 2 under ultrasound guide in prophylaxis of episodic migraine and chronic migraine in patients with failed oral prophylaxis medication.
According to guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic and chronic migraine,the primary and secondary outcome were monitoring followed by these research guideline
Read more
After informed consent, volunteer will be stratified random into 2 groups of injection agent at unilateral greater occipital nerve block on headache site under US guide by pain physician
- Normal saline
- 0.5% bupivacaine the injection was done 2 times between Week 0 and week 4 as to wean off placebo effect the volunteer will be monitor by pain diary at 1 month before intervention at week 0,4,8,12 and follow up at week 24 for Migraine Disability Assessment Test (MIDAS) ,Thai Hospital-Anxiety-depression index(Thai-HADS)
Read the detailed description
- Neurologist screening candidate volunteers for this study, following the inclusion and exclusion criteria
- Candidate volunteers attended pain clinic for he protocol detail about this research and informed consent
- After signing consent, Volunteers would be stratified randomization into 2 groups between Normal saline and bupivacaine
- Volunteers would be done base line headache diary for 1 month before performing the procedure (Week -4 to week0)
- At Week 0, Volunteers would be applied local anesthetic cream at skin injection site before done the procedure
- According to stratified randomization, Pain interventionist and also volunteers would be blinded to the group
- First Unilateral greater occipital nerve block at Cervical spine level 2 (C2) was done under ultrasound guide (Week0)
- Telemedicine Follow up at week 2
- Second Unilateral greater occipital nerve block at C2 level was done under ultrasound guide (Week4)
- Volunteers would be follow up via telemedicine and done headache diary until 3 months after 1st injection
- Volunteers would be follow up according to outcome monitoring protocol in Week 0,4,8,12,24
- Conditions
- Migraine Disorders
- Being tested
- Placebo, Bupivacaine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL
BupivacaineDrug
Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Use Normal saline 3 ml as the injection agent Receives: Drug: Placebo |
| Bupivacaine | Experimental | Use 0.5% Bupivacaine 3ml as the injection agent Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Frequency headache day /month
by using headache diary
Measured: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
change of migraine attack day /month from headache diary
by using headache diary
Measured: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Secondary outcomes (5)
change in severity of headache day per month (decrease of moderate-severe pain)
decrease of moderate-severe pain day per month compare to baseline by using headache diary
Measured: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Thai-Migraine Disability Assessment
Thai-Migraine Disability Assessment (MIDAS) ,Score 0 to 21+ ( 0-5 marks = little or no disability and more than 21+ =severe disability
Measured: at Week 12,24 compare to baseline
Thai-Hospital Anxiety and Depression Scale
Thai-Hospital Anxiety and Depression Scale (Thai HADS) , divided into anxiety and depression part ,if either of the score in each depression or anxiety more than 11 mean abnormal
Measured: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Healthcare outcomes/quality of life
by EuroQoL- (EQ-5D) measured health-related quality of life with 5 dimension (mobility, health care, usual activity, Pain, Anxiety/depression and in each of them had 5 grading 1-5 by 1 means no problem and 5 means extreme problem) after having score in each dimension, calculated utility score would be done
Measured: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Patient's reported outcome measurement (PGI-C)
Patient's reported outcome measurement (PGI-C), score grading 1-7 by 1 very much worse to very much improved , 7 means very much worse
Measured: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start30 May 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RAVIWON ATISOOK, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432127
- Sponsor's protocol ID
- 256/2024
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be consider again after data collection
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis in Patients With Failed Oral Prophylaxis Medication : A Randomized Controlled Study in Thailand
- ClinicalTrials.gov ID
- NCT06432127
- Acronym / sponsor ID
- 256/2024
- Conditions
- Migraine Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 May 2024 (actual)
- 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 goal of this randomized controlled study in Thailand. is to find if there is a role of local anesthetic greater occipital nerve block at Cervical spine level 2 under ultrasound guide in prophylaxis of episodic migraine and chronic migraine in patients with failed oral prophylaxis medication.
According to guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic and chronic migraine,the primary and secondary outcome were monitoring followed by these research guideline
After informed consent, volunteer will be stratified random into 2 groups of injection agent at unilateral greater occipital nerve block on headache site under US guide by pain physician
- Normal saline
- 0.5% bupivacaine the injection was done 2 times between Week 0 and week 4 as to wean off placebo effect the volunteer will be monitor by pain diary at 1 month before intervention at week 0,4,8,12 and follow up at week 24 for Migraine Disability Assessment Test (MIDAS) ,Thai Hospital-Anxiety-depression index(Thai-HADS)
Detailed description
- Neurologist screening candidate volunteers for this study, following the inclusion and exclusion criteria
- Candidate volunteers attended pain clinic for he protocol detail about this research and informed consent
- After signing consent, Volunteers would be stratified randomization into 2 groups between Normal saline and bupivacaine
- Volunteers would be done base line headache diary for 1 month before performing the procedure (Week -4 to week0)
- At Week 0, Volunteers would be applied local anesthetic cream at skin injection site before done the procedure
- According to stratified randomization, Pain interventionist and also volunteers would be blinded to the group
- First Unilateral greater occipital nerve block at Cervical spine level 2 (C2) was done under ultrasound guide (Week0)
- Telemedicine Follow up at week 2
- Second Unilateral greater occipital nerve block at C2 level was done under ultrasound guide (Week4)
- Volunteers would be follow up via telemedicine and done headache diary until 3 months after 1st injection
- Volunteers would be follow up according to outcome monitoring protocol in Week 0,4,8,12,24
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboUse Normal saline 3 ml as the injection agent |
| Bupivacaine | Experimental | Drug: BupivacaineUse 0.5% Bupivacaine 3ml as the injection agent |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 -65 years old
- Diagnosis as episodic migraine or chronic migraine and had indication to use migraine prophylaxis
- Volunteer prefer to use research procedure as first choice of migraine prophylaxis
- Volunteer already had migraine prophylaxis treatment but still has the one of these following problem 4.1 Frequency of migraine attack more than 4 times/month 4.2 Severe migraine headache \& disturb daily life in spite of using migraine prophylaxis 4.3 Having migraine medication side effect, either from prophylaxis or acute attack medication and cannot titration medication dosage 4.4 migraine attack not improved as using many migraine prophylaxis medications 4.5 Having contra-indication to use prophylaxis migraine medication or standard prophylaxis procedure such as botulinum toxin 4.6 Cannot take prophylaxis medication daily (low compliance) 4.7 Had financial problems in using standard prophylaxis migraine medication or procedure 4.8 Medication overuse headache
Key exclusion criteria (8 listed)
- Had these type of headache in combination with migraine
- Had contraindication on greater occipital nerve block injection at cervical spine level 2 under ultrasound-guided such as skin infection in needle site
- Allergy to local anesthetic
- Uncontrolled psychiatric disorder in 3 months before attending research
- Cannot understand or reading, writing Thai language
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 |
|---|---|---|
| PlaceboUnilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL | Drug | Placebo |
| BupivacaineUnilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL | Drug | Bupivacaine |
Primary outcome
change of Frequency headache day /month
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
by using headache diary
change of migraine attack day /month from headache diary
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
by using headache diary
5 secondary outcomes
change in severity of headache day per month (decrease of moderate-severe pain)
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Thai-Migraine Disability Assessment
Time frame: at Week 12,24 compare to baseline
Thai-Hospital Anxiety and Depression Scale
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Healthcare outcomes/quality of life
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Patient's reported outcome measurement (PGI-C)
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Undecided. will be consider again after data collection
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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.
RAVIWON ATISOOK, M.D. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine in people with Migraine Disorders, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 May 2024. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RAVIWON ATISOOK, M.D. (+66819140784, raviwon.ati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Frequency headache day /month (time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure). The study lists 2 primary outcomes in all. 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 29 May 2024.