Clinical trial NCT06432127: Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Migraine Disorders
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

1. Age 18 -65 years old
2. Diagnosis as episodic migraine or chronic migraine and had indication to use migraine prophylaxis
3. Volunteer prefer to use research procedure as first choice of migraine prophylaxis
4. 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

Exclusion Criteria:

1. Had these type of headache in combination with migraine

   * cervicogenic headache
   * occipital neuralgia
   * secondary headache
2. Had contraindication on greater occipital nerve block injection at cervical spine level 2 under ultrasound-guided such as skin infection in needle site
3. Allergy to local anesthetic
4. Uncontrolled psychiatric disorder in 3 months before attending research
5. Cannot understand or reading, writing Thai language

Primary outcomes:
measure: change of Frequency headache day /month
timeFrame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
measure: change of migraine attack day /month from headache diary
timeFrame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Secondary outcomes:
measure: change in severity of headache day per month (decrease of moderate-severe pain)
timeFrame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
measure: Thai-Migraine Disability Assessment
timeFrame: at Week 12,24 compare to baseline
measure: Thai-Hospital Anxiety and Depression Scale
timeFrame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
measure: Healthcare outcomes/quality of life
timeFrame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
measure: Patient's reported outcome measurement (PGI-C)
timeFrame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Raviwon Atisook
Study officials:
affiliation: Siriraj Hospital
name: RAVIWON ATISOOK, M.D.
role: PRINCIPAL_INVESTIGATOR
References: