NCT06432127Not yet recruitingPhase 4
Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis
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
Source: ClinicalTrials.gov · Last updated 29 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 15 May 2024
- Start date
- 30 May 2024
- Primary completion date
- Jan 2026
- Lead sponsor
- Mahidol University
- Diseases
- Migraine
- NCT number
- NCT06432127
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 108
- From 30 May 2024 to the primary completion date, Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled psychiatric disorder in 3 months before attending research
Other illness
- 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
Other
- Had these type of headache in combination with migraine
- cervicogenic headache
- occipital neuralgia
- secondary headache
- Cannot understand or reading, writing Thai language
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Raviwon Atisook Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.