Greater Occipital Nerve BlockNCT06122545
Chronic Migraine Prophylaxis: Ultrasound-Guided Greater Occipital Nerve Block Versus Medical Treatment
A study testing Greater Occipital Nerve Block, Medical Treatment and bupivacaine or onabotulinum toxin A injection. in people with Greater Occipital Nerve Block and Medical Treatment, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this work is to assess the efficacy of ultrasound guided greater occipital nerve block either by local anesthetic or by botulinum toxin in comparison to medical treatment in prevention of chronic migraine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Greater Occipital Nerve Block, Medical Treatment, Chronic Migraine
- What is being tested?
- Greater Occipital Nerve Block, Medical Treatment and bupivacaine or onabotulinum toxin A injection.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old.
- Both sexes.
- Patients with chronic migraine.
Who cannot join
- Age less than 18 years.
- Patients with medication overuse headache.
- Patients who had used acute pain medications within 24 hours prior to the study visit.
- History of injury to the area of the GON.
- Any prior adverse reactions to local anesthetics.
- Patients with impaired sensation in the occipital area.
- Any neurological or dermatological disease that may have affected skin sensation, bleeding tendency, any skull defect.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Sarah Z Elramady, Master, 00201122848960, sara.zakria@med.tanta.edu.eg
Mohamed O Rabei, MD
About this study
Official title: Chronic Migraine Prophylaxis: Comparative Study Between Ultrasound-Guided Greater Occipital Nerve Block and Medical Treatment
The aim of this work is to assess the efficacy of ultrasound guided greater occipital nerve block either by local anesthetic or by botulinum toxin in comparison to medical treatment in prevention of chronic migraine.
Read the detailed description
Primary headache disorders, particularly migraine and tension-type headache (TTH) are common worldwide and commonly result in widespread and substantial disability. Chronic migraine (CM) is defined as "headache occurring on 15 or more days per month for more than 3 months which has the features of migraine headache on at least 8 days per month".
The prevalence of CM in the general population is about 2%. It negatively affects emotional and family relationships, education, economic status, and general health. Migraine headaches might become quite severe and incapacitating for patients and management can be challenging even in experienced clinics.
Prophylactic interventions may include pharmacotherapy, behavioral therapy, physical therapy and other strategies. Management often requires the simultaneous use of these different therapeutic modalities. Once the headaches become refractory to conventional pharmacologic management minimally invasive techniques such as peripheral nerve blocks are feasible for pain relief and help to decrease the frequency of the attacks.
Preventive medications for chronic migraine treatment are less well studied than they are for episodic migraine. In addition, some trials evaluating treatment of chronic migraine are limited by one or more methodologic problems, such as small size, concomitant use of other prophylactic medications and/or lack of a specific headache diagnosis.
- Being tested
- Greater Occipital Nerve Block, Medical Treatment, bupivacaine or onabotulinum toxin A injection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greater Occipital Nerve BlockProcedure or surgery
Patients will receive Greater Occipital Nerve Block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.
Ultrasound-guided GONB will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery
Medical TreatmentOther
Patients who will receive medical treatment
bupivacaine or onabotulinum toxin A injection.Drug
bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.
| Study group | Role | What they receive |
|---|---|---|
| Greater Occipital Nerve Block | Experimental | Patients will receive greater occipital nerve block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection.
Ultrasound-guided Greater Occipital Nerve Block (GONB) will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery Receives: Procedure: Greater Occipital Nerve Block; Drug: bupivacaine or onabotulinum toxin A injection. |
| Medical Treatment | Experimental | Patients who will receive medical treatment Receives: Other: Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of headache
severity of headache will be assessed by the total Migraine Disability Assessment (MIDAS) score used to define four grades of migraine-related disability with grade I for "little or no disability" (0-5); grade II for "mild disability" (6-10); grade III for "moderate disability" (11-20); and grade IV for "severe disability" (≥ 21).
Measured: Follow up after 3 months
Secondary outcomes (2)
Reduction in headache days per month
Reduction in headache days per month will be assessed by total Headache Impact Test 6 (HIT 6) score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent.
Measured: Follow up after 3 months
Migraine specific quality of life
The total Migraine Disability Assessment (MIDAS) score range from 0 to 270 with the following disability classification criteria: (1) 0 to 5: slight or no disability, (2) 6 to 10: low levels of disability, (3) 11 to 20: moderate disability, and (4) 21 or above: severe disability.
Measured: Follow up after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 May 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Occipital Nerve BlockStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Zakaria Mohamed Elramady, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122545
- Sponsor's protocol ID
- 35459/4/22
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Migraine Prophylaxis: Comparative Study Between Ultrasound-Guided Greater Occipital Nerve Block and Medical Treatment
- ClinicalTrials.gov ID
- NCT06122545
- Acronym / sponsor ID
- 35459/4/22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this work is to assess the efficacy of ultrasound guided greater occipital nerve block either by local anesthetic or by botulinum toxin in comparison to medical treatment in prevention of chronic migraine.
Detailed description
Primary headache disorders, particularly migraine and tension-type headache (TTH) are common worldwide and commonly result in widespread and substantial disability. Chronic migraine (CM) is defined as "headache occurring on 15 or more days per month for more than 3 months which has the features of migraine headache on at least 8 days per month".
The prevalence of CM in the general population is about 2%. It negatively affects emotional and family relationships, education, economic status, and general health. Migraine headaches might become quite severe and incapacitating for patients and management can be challenging even in experienced clinics.
Prophylactic interventions may include pharmacotherapy, behavioral therapy, physical therapy and other strategies. Management often requires the simultaneous use of these different therapeutic modalities. Once the headaches become refractory to conventional pharmacologic management minimally invasive techniques such as peripheral nerve blocks are feasible for pain relief and help to decrease the frequency of the attacks.
Preventive medications for chronic migraine treatment are less well studied than they are for episodic migraine. In addition, some trials evaluating treatment of chronic migraine are limited by one or more methodologic problems, such as small size, concomitant use of other prophylactic medications and/or lack of a specific headache diagnosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Greater Occipital Nerve Block | Experimental | Procedure: Greater Occipital Nerve Block, Drug: bupivacaine or onabotulinum toxin A injection.Patients will receive greater occipital nerve block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection. Ultrasound-guided Greater Occipital Nerve Block (GONB) will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery |
| Medical Treatment | Experimental | Other: Medical TreatmentPatients who will receive medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Both sexes.
- Patients with chronic migraine.
Key exclusion criteria (7 listed)
- Age less than 18 years.
- Patients with medication overuse headache.
- Patients who had used acute pain medications within 24 hours prior to the study visit.
- History of injury to the area of the GON.
- Any prior adverse reactions to local anesthetics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Greater Occipital Nerve BlockPatients will receive Greater Occipital Nerve Block (GONB) either with local anesthetic (bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection. Ultrasound-guided GONB will be performed to more accurately locate the nerve through searching for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process and injection will be done medial to the artery | Procedure or surgery | Greater Occipital Nerve Block |
| Medical TreatmentPatients who will receive medical treatment | Other | Medical Treatment |
| bupivacaine or onabotulinum toxin A injection.bupivacaine 0.5% 1.5 mL) or with onabotulinum toxin A injection. | Drug | Greater Occipital Nerve Block |
Primary outcome
severity of headache
Time frame: Follow up after 3 months
severity of headache will be assessed by the total Migraine Disability Assessment (MIDAS) score used to define four grades of migraine-related disability with grade I for "little or no disability" (0-5); grade II for "mild disability" (6-10); grade III for "moderate disability" (11-20); and grade IV for "severe disability" (≥ 21).
2 secondary outcomes
Reduction in headache days per month
Time frame: Follow up after 3 months
Migraine specific quality of life
Time frame: Follow up after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greater Occipital Nerve Block, Medical Treatment and bupivacaine or onabotulinum toxin A injection. in people with Greater Occipital Nerve Block and Medical Treatment, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Z Elramady, Master (00201122848960, sara.zakria@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of headache (time frame: Follow up after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.