## Protocol Section
### Identification Module
**NCT ID:** NCT06432127

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 256/2024
#### Organization
**Class:** OTHER
**Full Name:** Mahidol University
### Status Module
#### Completion Date
**Date:** 2027-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mahidol University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Migraine Disorders

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 108

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Use Normal saline 3 ml as the injection agent

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Use 0.5% Bupivacaine 3ml as the injection agent

**Intervention Names:**

- Drug: Bupivacaine

**Label:** Bupivacaine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Placebo

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

**Name:** Placebo

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Bupivacaine

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

**Name:** Bupivacaine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** by using headache diary

**Measure:** change of Frequency headache day /month

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

**Description:** by using headache diary

**Measure:** change of migraine attack day /month from headache diary

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

#### Secondary Outcomes

**Description:** decrease of moderate-severe pain day per month compare to baseline by using headache diary

**Measure:** change in severity of headache day per month (decrease of moderate-severe pain)

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

**Description:** Thai-Migraine Disability Assessment (MIDAS) ,Score 0 to 21+ ( 0-5 marks = little or no disability and more than 21+ =severe disability

**Measure:** Thai-Migraine Disability Assessment

**Time Frame:** at Week 12,24 compare to baseline

**Description:** 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

**Measure:** Thai-Hospital Anxiety and Depression Scale

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

**Description:** 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

**Measure:** Healthcare outcomes/quality of life

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

**Description:** 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

**Measure:** Patient's reported outcome measurement (PGI-C)

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

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** raviwon.ati@gmail.com

**Name:** RAVIWON ATISOOK, M.D.

**Phone:** +66819140784

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bangkok

**Contacts:**

***Contact 1:***

- **Email:** raviwon.ati@gmail.com

- **Name:** Raviwon Atisook, M.D

- **Phone:** +66819140784

- **Role:** CONTACT

**Country:** Thailand

**Facility:** Raviwon Atisook

**Zip:** 10700

#### Overall Officials

**Official 1:**

**Affiliation:** Siriraj Hospital

**Name:** RAVIWON ATISOOK, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** will be consider again after data collection

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000051270

- Term: Headache Disorders, Primary

- ID: D000020773

- Term: Headache Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M9351

- Name: Headache

- Relevance: HIGH

- As Found: Headache

- ID: M11852

- Name: Migraine Disorders

- Relevance: HIGH

- As Found: Migraine

- ID: M22529

- Name: Headache Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26657

- Name: Headache Disorders, Primary

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008881

- Term: Migraine Disorders

- ID: D000006261

- Term: Headache

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002045

- Term: Bupivacaine

### Misc Info Module

- Version Holder: 2024-05-31
