Chronic MigraineNCT06684249
Efficacy of Nerve Block Versus Botox in Chronic Migraine Management
A study testing Nerve Block Injections and Botulinum Toxin A in people with Chronic Migraine and Chronic Migraine, Headache, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to determine whether nerve block injections (specifically, supratrochlear and greater occipital nerve injections) are as effective as Botulinum toxin A (Botox) injections in treating chronic migraine in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine, Chronic Migraine, Headache
- What is being tested?
- Nerve Block Injections and Botulinum Toxin A
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2024to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years.
- Diagnosis of chronic migraine, defined as having headaches on 15 or more days per month for more than three months, with at least 8 of those days meeting criteria for migraine.
- Ability to provide informed consent and comply with study requirements.
- No changes in prophylactic migraine medications in the last 3 months.
Who cannot join
- History of allergy or hypersensitivity to local anesthetics or Botulinum toxin.
- Previous nerve block or Botox treatment within the last 6 months.
- Significant comorbid psychiatric or neurological disorders that could interfere with study participation or evaluation.
- Pregnancy or breastfeeding.
- Contraindications to either treatment as per product labels.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University, Faculty of Medicine
Zagazig, Sharqia Province, 44519
Ahmed A Bessar, MD, PhD, +201000089595, ahmedawadbessar@gmail.com
About this study
Official title: A Randomized Controlled Trial Comparing the Efficacy of Supratrochlear and Greater Occipital Nerve Blocks to Botulinum Toxin A in the Management of Chronic Migraine
The goal of this clinical trial is to determine whether nerve block injections (specifically, supratrochlear and greater occipital nerve injections) are as effective as Botulinum toxin A (Botox) injections in treating chronic migraine in adults.
The main questions it aims to answer are:
Read more
- Do nerve block injections reduce the number of monthly migraine days compared to baseline?
- Are there any differences in the frequency of migraine-related symptoms between the nerve block and Botox treatment groups?
- Which treatment leads to higher patient satisfaction and improved quality of life?
Participants in this study will:
- Receive either nerve block injections or Botox injections every 12 weeks.
- Visit the clinic once every month for follow-ups and assessments.
- Maintain a headache diary to record the frequency and severity of their migraines and any adverse effects experienced.
- Researchers will compare the outcomes of the two groups to determine if one treatment is superior in terms of efficacy and patient satisfaction.
Read the detailed description
This randomized controlled trial aims to assess the comparative efficacy of supratrochlear and greater occipital nerve block injections versus Botulinum toxin A (Botox) injections in the management of chronic migraine. Chronic migraine, characterized by headaches on fifteen or more days per month, significantly impacts quality of life and productivity. Effective management strategies are crucial for improving patient outcomes.
Study Design: Participants will be randomly assigned to one of two treatment arms:
- Nerve block injections group, receiving supratrochlear and greater occipital nerve injections with a combination of local anesthetics and corticosteroids.
- Botox injections group, receiving the standard Botox treatment protocol recommended for chronic migraine.
Each participant will receive their assigned treatment once every 12 weeks for a total of 6 months.
The primary endpoint will be the reduction in the number of migraine days per month from baseline to the end of the treatment period. Secondary endpoints will include changes in migraine severity, frequency of acute medication use, patient-reported outcomes on pain and migraine-related disability, and treatment safety and tolerability.
Procedures:
- Baseline evaluation will include medical history, migraine frequency and severity assessment, and previous treatment history.
- Follow-up visits will occur monthly, with additional evaluations at the end of the treatment period.
- Participants will be asked to maintain a headache diary throughout the study period to record migraine occurrence, characteristics, and any acute medication use.
Significance: This study will provide valuable data on the efficacy of nerve block injections compared to Botox, potentially offering an alternative treatment for patients who do not respond well to Botox injections. Additionally, findings may influence clinical practice guidelines and patient management strategies for chronic migraine.
Relevance: Given the burden of chronic migraine and the variable patient response to existing therapies, exploring alternative treatments is crucial. This study addresses this need by comparing two distinct therapeutic approaches, thus contributing to personalized migraine management.
- Conditions
- Chronic Migraine, Chronic Migraine, Headache
- Being tested
- Nerve Block Injections, Botulinum Toxin A
- Keywords
- Migraine, Chronic Migraine, Nerve Block, Botulinum Toxin, Botox, Headache
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Block InjectionsProcedure or surgery
Also called Supratrochlear and Greater Occipital Nerve Block
This intervention involves the administration of supratrochlear and greater occipital nerve block injections. The injections consist of a mixture of local anesthetics and corticosteroids, designed to reduce the frequency and severity of migraine episodes. The procedure will be repeated every 12 weeks for a total duration of 6 months to assess the long-term efficacy and safety in managing chronic migraine.
Botulinum Toxin ADrug
Also called Botox
Participants in this arm will receive Botulinum toxin A injections as per the PREEMPT protocol tailored for chronic migraine treatment. The treatment involves multiple injections around the head and neck regions, administered every 12 weeks over a 6-month period. This standard approach aims to reduce migraine frequency through neuromodulation of pain pathways.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Block Therapy | Experimental | Participants in this group will receive supratrochlear and greater occipital nerve injections consisting of a combination of local anesthetics and corticosteroids. Injections will be administered once every 12 weeks for a total of 6 months. Receives: Procedure: Nerve Block Injections |
| Botulinum Toxin A (Botox) Therapy | Active comparator | Participants in this group will receive Botulinum toxin A (Botox) injections according to the standard PREEMPT injection protocol for chronic migraine. Injections will be administered once every 12 weeks for a total of 6 months. Receives: Drug: Botulinum Toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Monthly Migraine Days
The primary outcome is the reduction in the number of migraine days per month. This measure assesses the effectiveness of nerve block injections versus Botox injections in decreasing the frequency of migraine days from baseline to the end of the treatment period.
Measured: Baseline, 3 months, 6 months post-procedure
Secondary outcomes (4)
Change in Migraine Severity
Assessment of changes in the severity of migraine episodes using a Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100, where 0 represents "no pain" and 100 represents "worst possible pain". This measure evaluates whether the treatment reduces the pain intensity of migraines.
Measured: Baseline, 3 months, 6 months post-procedure
Frequency of Acute Medication Use
Evaluation of the change in the frequency of acute migraine medication use, documenting any reductions as a result of the treatment.
Measured: Baseline, 3 months, 6 months post-procedure
Patient Satisfaction and Quality of Life
Measured using the Migraine-Specific Quality of Life Questionnaire (MSQ), this outcome assesses changes in the patient's quality of life and satisfaction with treatment.
Measured: Baseline, 3 months, 6 months post-procedure
Adverse Events
Monitoring and recording any adverse events associated with the treatments to evaluate safety profiles of the nerve block and Botox interventions.
Measured: Throughout the study period (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start10 Nov 2024
- Primary completion10 May 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel design comparing nerve block injections with Botox injections in chronic migraine management.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Awad Bessar, Zagazig University
- Investigators
- Ahmed Bessar, MD, PhD, Principal investigator, Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684249
- Sponsor's protocol ID
- MigraineNBvsBotox
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficacy of Supratrochlear and Greater Occipital Nerve Blocks to Botulinum Toxin A in the Management of Chronic Migraine
- ClinicalTrials.gov ID
- NCT06684249
- Acronym / sponsor ID
- MigraineNBvsBotox
- Conditions
- Chronic Migraine, Chronic Migraine, Headache
- Keywords
- Migraine, Chronic Migraine, Nerve Block, Botulinum Toxin, Botox, Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 12 Nov 2024 (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 goal of this clinical trial is to determine whether nerve block injections (specifically, supratrochlear and greater occipital nerve injections) are as effective as Botulinum toxin A (Botox) injections in treating chronic migraine in adults.
The main questions it aims to answer are:
- Do nerve block injections reduce the number of monthly migraine days compared to baseline?
- Are there any differences in the frequency of migraine-related symptoms between the nerve block and Botox treatment groups?
- Which treatment leads to higher patient satisfaction and improved quality of life?
Participants in this study will:
- Receive either nerve block injections or Botox injections every 12 weeks.
- Visit the clinic once every month for follow-ups and assessments.
- Maintain a headache diary to record the frequency and severity of their migraines and any adverse effects experienced.
- Researchers will compare the outcomes of the two groups to determine if one treatment is superior in terms of efficacy and patient satisfaction.
Detailed description
This randomized controlled trial aims to assess the comparative efficacy of supratrochlear and greater occipital nerve block injections versus Botulinum toxin A (Botox) injections in the management of chronic migraine. Chronic migraine, characterized by headaches on fifteen or more days per month, significantly impacts quality of life and productivity. Effective management strategies are crucial for improving patient outcomes.
Study Design: Participants will be randomly assigned to one of two treatment arms:
- Nerve block injections group, receiving supratrochlear and greater occipital nerve injections with a combination of local anesthetics and corticosteroids.
- Botox injections group, receiving the standard Botox treatment protocol recommended for chronic migraine.
Each participant will receive their assigned treatment once every 12 weeks for a total of 6 months.
The primary endpoint will be the reduction in the number of migraine days per month from baseline to the end of the treatment period. Secondary endpoints will include changes in migraine severity, frequency of acute medication use, patient-reported outcomes on pain and migraine-related disability, and treatment safety and tolerability.
Procedures:
- Baseline evaluation will include medical history, migraine frequency and severity assessment, and previous treatment history.
- Follow-up visits will occur monthly, with additional evaluations at the end of the treatment period.
- Participants will be asked to maintain a headache diary throughout the study period to record migraine occurrence, characteristics, and any acute medication use.
Significance: This study will provide valuable data on the efficacy of nerve block injections compared to Botox, potentially offering an alternative treatment for patients who do not respond well to Botox injections. Additionally, findings may influence clinical practice guidelines and patient management strategies for chronic migraine.
Relevance: Given the burden of chronic migraine and the variable patient response to existing therapies, exploring alternative treatments is crucial. This study addresses this need by comparing two distinct therapeutic approaches, thus contributing to personalized migraine management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group parallel design comparing nerve block injections with Botox injections in chronic migraine management.
| Arm | Type | Receives |
|---|---|---|
| Nerve Block Therapy | Experimental | Procedure: Nerve Block InjectionsParticipants in this group will receive supratrochlear and greater occipital nerve injections consisting of a combination of local anesthetics and corticosteroids. Injections will be administered once every 12 weeks for a total of 6 months. |
| Botulinum Toxin A (Botox) Therapy | Active comparator | Drug: Botulinum Toxin AParticipants in this group will receive Botulinum toxin A (Botox) injections according to the standard PREEMPT injection protocol for chronic migraine. Injections will be administered once every 12 weeks for a total of 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 65 years.
- Diagnosis of chronic migraine, defined as having headaches on 15 or more days per month for more than three months, with at least 8 of those days meeting criteria for migraine.
- Ability to provide informed consent and comply with study requirements.
- No changes in prophylactic migraine medications in the last 3 months.
Key exclusion criteria (5 listed)
- History of allergy or hypersensitivity to local anesthetics or Botulinum toxin.
- Previous nerve block or Botox treatment within the last 6 months.
- Significant comorbid psychiatric or neurological disorders that could interfere with study participation or evaluation.
- Pregnancy or breastfeeding.
- Contraindications to either treatment as per product labels.
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 |
|---|---|---|
| Nerve Block InjectionsAlso: Supratrochlear and Greater Occipital Nerve BlockThis intervention involves the administration of supratrochlear and greater occipital nerve block injections. The injections consist of a mixture of local anesthetics and corticosteroids, designed to reduce the frequency and severity of migraine episodes. The procedure will be repeated every 12 weeks for a total duration of 6 months to assess the long-term efficacy and safety in managing chronic migraine. | Procedure or surgery | Nerve Block Therapy |
| Botulinum Toxin AAlso: BotoxParticipants in this arm will receive Botulinum toxin A injections as per the PREEMPT protocol tailored for chronic migraine treatment. The treatment involves multiple injections around the head and neck regions, administered every 12 weeks over a 6-month period. This standard approach aims to reduce migraine frequency through neuromodulation of pain pathways. | Drug | Botulinum Toxin A (Botox) Therapy |
Primary outcome
Reduction in Monthly Migraine Days
Time frame: Baseline, 3 months, 6 months post-procedure
The primary outcome is the reduction in the number of migraine days per month. This measure assesses the effectiveness of nerve block injections versus Botox injections in decreasing the frequency of migraine days from baseline to the end of the treatment period.
4 secondary outcomes
Change in Migraine Severity
Time frame: Baseline, 3 months, 6 months post-procedure
Frequency of Acute Medication Use
Time frame: Baseline, 3 months, 6 months post-procedure
Patient Satisfaction and Quality of Life
Time frame: Baseline, 3 months, 6 months post-procedure
Adverse Events
Time frame: Throughout the study period (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
Related trials for Chronic Migraine
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
MMA Embolization for Refractory Chronic Migraine
Migraine Disorders
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
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.
Ahmed Bessar, MD, PhD principal investigator
Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Block Injections and Botulinum Toxin A in people with Chronic Migraine and Chronic Migraine, Headache, run by Zagazig 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Bessar, MD, PhD (+201000089595, Ahmedawadbessar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Monthly Migraine Days (time frame: Baseline, 3 months, 6 months post-procedure). 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 12 Nov 2024.