Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432127
• Other study ID #: 256/2024
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 30, 2024
• Est. completion date: January 2027

Study information

• Verified date: May 2024
• Source: Mahidol University
• Contact: RAVIWON ATISOOK, M.D.
• Phone: +66819140784
• Email: raviwon.ati[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders

Intervention

Drug:
• Placebo
Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL
• Bupivacaine
Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL

Locations

Country	Name	City	State
Thailand	Raviwon Atisook	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of Frequency headache day /month	by using headache diary	at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Primary	change of migraine attack day /month from headache diary	by using headache diary	at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Secondary	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	at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Secondary	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	at Week 12,24 compare to baseline
Secondary	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	at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Secondary	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	at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Secondary	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	at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure