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

NCT06432127 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 256/2024
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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)

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• change in severity of headache day per month (decrease of moderate-severe pain)

  at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure

• Thai-Migraine Disability Assessment

  at Week 12,24 compare to baseline

• Thai-Hospital Anxiety and Depression Scale

  at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure

• Healthcare outcomes/quality of life

  at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure

• Patient's reported outcome measurement (PGI-C)

  at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Use Normal saline 3 ml as the injection agent

Drug: Placebo

Bupivacaine

EXPERIMENTAL

Use 0.5% Bupivacaine 3ml as the injection agent

Drug: Bupivacaine

Interventions

Placebo DRUG

Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL

Placebo

Bupivacaine DRUG

Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Raviwon Atisook

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• RAVIWON ATISOOK, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RAVIWON ATISOOK, M.D.

CONTACT

+66819140784; raviwon.ati@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 29, 2024
• Study Start: May 30, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

TH (1)