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NCT Number: NCT06432127

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

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)

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. 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

    by using headache diary

  2. 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

    by using headache diary

Secondary outcomes

  1. 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

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

  2. Thai-Migraine Disability Assessment

    Time frame: at Week 12,24 compare to baseline

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

  3. 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

    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

  4. Healthcare outcomes/quality of life

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

    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

  5. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

RAVIWON ATISOOK, M.D.

CONTACT

[email protected]

+66819140784

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 29, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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