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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Placebo; Drug: Bupivacaine

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 Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: RAVIWON ATISOOK, M.D.; Phone Number: +66819140784; Email: raviwon.ati@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Raviwon Atisook
    • Contact: Raviwon Atisook, M.D; Phone Number: +66819140784; Email: raviwon.ati@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Use Normal saline 3 ml as the injection agent	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
Experimental: Bupivacaine; Use 0.5% Bupivacaine 3ml as the injection agent	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: RAVIWON ATISOOK, M.D., Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 256/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: will be consider again after data collection

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No