Plain English Summary
Background and study aims
The sphenopalatine ganglion is a collection of nerve cells located behind the nose on each side of the face. Due to its complex connections to important structures in the head and meninges (brain coverings), it plays an important role in migraine headaches and other headache and facial pain conditions, such as cluster headache. Injecting certain medications into this structure helps relieve migraine headaches as well as its associated symptoms, such as tearing, runny nose and light sensitivity. The treatment is done using simple safe devices (called catheters) inserted through the nose, using lidocaine solution (which is used in the dentist office for numbing the gum). The treatment is simple and safe with effect that may last for days or longer, and can be repeated at regular intervals to help reduce migraine attack severity and frequency. The aim of this study is to treat patients who are known to have migraine and present with an acute attack not responding to usual pain medications.
Who can participate?
Adults aged 18 to 60 years old who have migraine headaches.
What does the study involve?
Participants have a numbering medication called lidocaine injected using the SPHENOCATH, which is a small soft tube. The medicine is injected while the patient is lying down and is directed at a group of nerve cells called the sphenopalatine ganglion, located behind the nose on each side. Participants are asked to remain lying down on their back of 10 minutes in order to ensure that the medicine reached the proper place.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement in their headache symptoms. The procedure is very safe and well-tolerated, with few side effects, such as numbness of the throat (usually lasting less than 30 minutes), mild nausea and mild dizziness that go away in few minutes. The procedure can safely repeated every 2-4 weeks as needed, and the treatment effect usually lasts few days to few weeks.
Where is the study run from?
University Medical Center, King Abdullah Medical City (Bahrain)
When is the study starting and how long is it expected to run for?
February 2017 to October 2017
Who is funding the study?
University Medical Center, King Abdullah Medical City (Bahrain)
Who is the main contact?
Dr Mohamed Albinfalah (Scientific)
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
70809
Study information
Scientific title
Sphenopalatine ganglion block for the treatment of acute migraine headache
Acronym
Study hypothesis
Although there are currently many options for acute migraine treatment, such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDS), triptans, combinations analgesics, and anti-emetics, these treatment options are often suboptimal, with inadequate efficacy and significant side effects. In addition, several studies have shown that migraine patients with poor response to acute treatment are at increased risk for transformation to chronic migraine (CM), with roughly 2.5-3.5-fold greater odds of developing CM; patients with a moderate or better acute treatment efficacy did not have a significant increased risk. Therefore, there is a continuous need for new treatment modalities to address the therapeutic needs of migraine sufferers, especially those with frequent and disabling attacks.
Sphenopalatine ganglion (SPG) block has gained interest as an effective treatment modality for migraine and other headache and facial pain syndromes. The SPG, which is the major parasympathetic outflow to the cranial and facial structures, is a reasonable target to help relief pain and autonomic features seen in migraine and other headache and facial pain conditions such as cluster headache and trigeminal neuralgia.
Ethics approval(s)
Institutional Review Board of University Medical Center at King Abdullah Medical City, 20/02/2017
Study design
Open uncontrolled retrospective study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute migraine headache
Intervention
Prior to procedure, the nose is inspected for any obstruction, and xylometazoline 0.05% nasal drops (one drop in each nostril) are used to help open the nasal passages. Face temperature is recorded using temperature sensor skin probes put on both cheeks. A small amount of 2% lidocaine jelly is installed in each nostril for patients’ comfort, using a needless syringe. Each patient received a single treatment of transnasal SPG block with 2 cc of 2% lidocaine in each nostril in the supine position with head extension, delivered using the Sphenocath® device. This is a small flexible sheath with a curved tip. It is inserted through the anterior nasal passage parallel to nasal septum and above the middle turbinate. Once in place, the inner catheter is advanced to administer 2cc of 2% lidocaine. It is then removed and the procedure is repeated on the other side. Typically after the block, there is an increase in face temperature by 1 to 2 degrees Celsius and/or tearing. The patient is instructed to remain in the same position for 10 minutes. Pain is assessed using numeric rating scale (NRS), where 0 is no pain and 10 is worst pain imaginable; this was recorded at baseline, 15 minutes, 2 hours and 24 hours after the procedure. We also recorded patient global impression of change (PGIC; very poor, poor, no change, good, very good) at 2 hours and 24 hours post-procedure.
Intervention type
Device
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
1. Percentage of patients free of headache using the numeric rating scale at 15 minutes, 2 hours and 24 hours
2. Pain is assessed using the numeric rating scale (NRS) at baseline, 15 minutes, 2 hours and 24 hours after the procedure
Secondary outcome measures
1. Headache relief rate, defined as percentage of patients with 50% or more reduction in headache intensity is measured using the numeric rating scale (NRS) at 15 minutes, 2 hours and 24 hours (using the NRS)
2. Change in NRS from baseline to 15 minutes, 2 hours and 24 hours post-treatment
3. Patient global impression of change (on a scale: very poor, poor, no change, good, very good), measuring effects on headache and its associated symptoms, and tolerability) at 2 hours and 24 hours
4. All adverse events reported by the patients up to 24 hours post-procedure
Overall study start date
01/02/2017
Overall study end date
31/10/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 18 to 60 years of age
2. Diagnosed with migraine headache (according to International Classification of Headache Disorders-3 Beta since at least one year)
3. Present with moderate to severe headache not responding to abortive medications
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
55
Total final enrolment
55
Participant exclusion criteria
1. Patients with medication overuse headache
2. Bleeding disorders
3. Abnormal neurological examination
4. History of allergy to local anesthetics
Recruitment start date
01/03/2017
Recruitment end date
30/09/2017
Locations
Countries of recruitment
Bahrain
Study participating centre
University Medical Center, King Abdullah Medical City
Manama
26671
Bahrain
Sponsor information
Organisation
University Medical Center, King Abdullah Medical City
Sponsor details
P.O. Box 26671
Manama
26671
Bahrain
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Center, King Abdullah Medical City
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. Additional documentations such as study protocol, statistical analysis, will be available.
Intention to publish date
30/06/2018
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Mohamed Albinfalah (mfalahmd@gmail.com).
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/05/2018 | 11/02/2022 | Yes | No |