Chronic MigrainePhase 4NCT05679765

Efficacy of GONB in Patients of Migraine

A Phase 4 study testing Greater Occipital Nerve Block with dexamethasone and lidocaine and Greater Occipital Nerve Block with 0.9% saline in people with Chronic Migraine and Headache, run by Pain Medicine Department at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Chronic Migraine, Headache
What is being tested?: Greater Occipital Nerve Block with dexamethasone and lidocaine and Greater Occipital Nerve Block with 0.9% saline
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 sitePakistan
Study dates: 1 Apr 2022to 31 Aug 2022
Phase: Phase 4
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients between 18 to 60 years
diagnosed case of migraine

Who cannot join

Patients with known allergies to local anaesthetics
pregnancy
history of cranial or cervical surgery
head injury
headaches secondary to medication overuse
patients with uncontrolled systemic disease like blood pressure, diabetes mellitus

Show all 10Show fewer

hypo or hyperthyroidism
patient who had already received GONB or botulinum toxin type A therapy within last 6 months
major psychiatric disorder
history of chronic pain syndromes

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Pain Medicine Department
Lahore

Other trials in Pakistan

About this study

Official title: Analgesic Efficacy of Ultrasound-guided Greater Occipital Nerve Block in Patients of Chronic Migraine

The study was carried to determine the analgesic efficacy of greater occipital nerve block in patients of migraine. It was a randomised controlled which took place from april 2022 - october 2022. Fifty patients suffering from migraine were included in the study. Patients in Group G were given greater occipital nerve block (GONB) with lignocaine and dexamethasone under ultrasound guidance while those in Group S were given saline 0.9% as placebo. Pain score using Numeric Rating Scale and number of headache days was assessed at four,eight and twelve weeks after the procedure as a primary outcome. Total headache days were recorded as a secondary outcome.

Conditions: Chronic Migraine, Headache
Being tested: Greater Occipital Nerve Block with dexamethasone and lidocaine, Greater Occipital Nerve Block with 0.9% saline
Medical subject headings: Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Greater Occipital Nerve Block with dexamethasone and lidocaineDrug
Also called GONB with dexamethasone and lidocaine
Ultrasound guided Greater occipital nerve block on the side of headache
Greater Occipital Nerve Block with 0.9% salineDrug
Also called GONB with 0.9% saline
Ultrasound guided Greater occipital nerve block on the side of headache

Study groups in NCT05679765
Study group	Role	What they receive
Group G	Experimental	Greater occipital nerve block (GONB) under ultrasound guidance with lidocaine and dexamethasone on the side of headache Receives: Drug: Greater Occipital Nerve Block with dexamethasone and lidocaine; Drug: Greater Occipital Nerve Block with 0.9% saline
Group S	Active comparator	Greater occipital nerve block (GONB) under ultrasound guidance on the side of headache with 0.9% Saline (Placebo) Receives: Drug: Greater Occipital Nerve Block with dexamethasone and lidocaine; Drug: Greater Occipital Nerve Block with 0.9% saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Analgesic efficacy
Change in Pain score assessed on Numeric Rating Scale (NRS) which ranges from 0 to 10. 0 is no pain and 10 is maximum pain.
Measured: 12 weeks

Secondary outcomes (1)

Headache days
Number of headache days over the course of study period.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202231 Aug 2022

First posted11 Jan 2023
Study start1 Apr 2022
Primary completion31 Aug 2022
Study completion31 Aug 2022

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.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05679765
Sponsor's protocol ID: GONB for migraine
Status last verified: Jan 2023
First submitted: 7 Dec 2022
Last updated: 12 Jan 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Chronic Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analgesic Efficacy of Ultrasound-guided Greater Occipital Nerve Block in Patients of Chronic Migraine
ClinicalTrials.gov ID: NCT05679765
Acronym / sponsor ID: GONB for migraine
Conditions: Chronic Migraine, Headache
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Pain Medicine DepartmentUniversity, hospital or other
Study start: 1 Apr 2022 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 11 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Group G	Experimental	Drug: Greater Occipital Nerve Block with dexamethasone and lidocaine, Drug: Greater Occipital Nerve Block with 0.9% salineGreater occipital nerve block (GONB) under ultrasound guidance with lidocaine and dexamethasone on the side of headache
Group S	Active comparator	Drug: Greater Occipital Nerve Block with dexamethasone and lidocaine, Drug: Greater Occipital Nerve Block with 0.9% salineGreater occipital nerve block (GONB) under ultrasound guidance on the side of headache with 0.9% Saline (Placebo)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Patients between 18 to 60 years
diagnosed case of migraine

Key exclusion criteria (10 listed)

Patients with known allergies to local anaesthetics
pregnancy
history of cranial or cervical surgery
head injury
headaches secondary to medication overuse

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 Block with dexamethasone and lidocaineAlso: GONB with dexamethasone and lidocaineUltrasound guided Greater occipital nerve block on the side of headache	Drug	Group G, Group S
Greater Occipital Nerve Block with 0.9% salineAlso: GONB with 0.9% salineUltrasound guided Greater occipital nerve block on the side of headache	Drug	Group G, Group S

Primary outcome

Analgesic efficacy
Time frame: 12 weeks
Change in Pain score assessed on Numeric Rating Scale (NRS) which ranges from 0 to 10. 0 is no pain and 10 is maximum pain.

1 secondary outcome

Headache days
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.

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. This study is not recruiting at the moment.

Moazzam Ali principal investigator

Pain Medicine Department

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 10 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: finished, as of the sponsor's last update on 12 Jan 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 Pakistan. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analgesic efficacy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05679765.

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 Jan 2023.