Condition category
Nervous System Diseases
Date applied
18/12/2017
Date assigned
08/01/2018
Last edited
08/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohamed Albinfalah

ORCID ID

Contact details

University Medical Center
King Abdullah Medical City
PO Box 26671
Manama
109
Bahrain

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/02/2017

Overall trial end date

31/10/2017

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

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

Trial 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

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.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Mohamed Albinfalah (mfalahmd@gmail.com).

Intention to publish date

30/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes