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| Name | Class |
|---|---|
| Louise and Alan Edwards Foundation | UNKNOWN |
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Primary Objective The primary objective of the study is to assess whether transnasal sphenopalatine ganglion block using the device TX360 reduces intensity and severity of the Post-Traumatic Headache in adolescents.
Secondary Objectives
The study will also evaluate:
The sphenopalatine ganglion (SPG) is a large network of neurons that is easily accessible through the middle turbinate. The SPG is composed of branches from V1 and V2 of the trigeminal nerve and interconnects with sympathetic and parasympathetic autonomic fibers.6 The SPG has been successfully targeted transnasally to treat headache disorders and associated autonomic symptoms in adults.7 SPG blockade has been used in adults for treating several headache and facial pain conditions such as migraine, cluster headache, and trigeminal neuralgia.8 To our knowledge, there has not been any similar study done in children and adolescents.
The Tx360® device (Tian Medical Inc., Lombard, IL, USA) allows for noninvasive blockade of the SPG using a small catheter below the middle turbinate of the nose that is administered just beyond the pterygopalatine fossa. Regarding the efficacity of Tx360®, recent studies show that repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device was well-tolerated and effective at decreasing baseline headache intensity in adults.6
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | The participants randomized into this arm will receive the SPG block with 0.5% bupivacaine. |
|
| Placebo Arm | Placebo Comparator | The participants randomized into this arm will receive the SPG block with saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine ganglion block with 0.5% bupivacaine | Other | Repetitive SPG blockade using 0.5% bupivacaine delivered with the Tx360® device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Headache per Month | Number of Days of Headache per Month | up to 3 months after last intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment during the headache | using a Questionnaire that includes the following : Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, that fits best to their pain intensity . Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible. | we will ask after every intervention and up to 3 months after last intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Type of Adverse events | By asking about side effects as : Dizziness, drowsiness, lacrimation, mouth numbness, throat, nasal irritation, bleeding, others. we will collect the number of side effects encountered as well as their severity . | up to 3 months after last intervention |
Inclusion Criteria:
Subjects will be included if they meet all the following criteria:
Aged between 10 and 17.5 years old at the start of treatment
Daily Headache, within these categories:
Diagnostic criteria for persistent headache attributed to mild traumatic injury to the head:
Persistent headache attributed to traumatic injury to the head:
A. Any headache fulfilling criteria C and D B. Traumatic injury to the head1 has occurred
C. Headache is reported to have developed within 7 days after one of the following:
B. Head injury fulfilling both of the following:
Associated with none of the following:
Associated with one or more of the following symptoms and/or signs:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Vigouroux | Contact | 5144124448 | marie.Vigouroux@mail.mcgill.ca | |
| Nada A Mohamed, MD | Contact | 5144124448 | nada.mohamed@mail.mcgill.ca |
| Name | Affiliation | Role |
|---|---|---|
| Pablo Ingelmo, MD | Research Institute at the Montreal Childrens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre (MUHC) - Montreal Children's Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34356585 | Background | Kouri M, Somaini M, Cardenas VHG, Niburski K, Vigouroux M, Ingelmo P. Transnasal Sphenopalatine Ganglion Block for the Preventive Treatment of Chronic Daily Headache in Adolescents. Children (Basel). 2021 Jul 18;8(7):606. doi: 10.3390/children8070606. |
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| Sphenopalatine ganglion block with saline | Other | Repetitive SPG blockade using saline delivered with the Tx360® device. |
|
| Patient Global Impression of Change scale ( PGIC) | Patient Global Impression of Change scale ( PGIC) is a rating scale offered through a questionnaire that is most commonly used in clinically important changes after treatments and it has been used extensively in studies of musculoskeletal conditions. The patient is asked to describe changes in limitation, symptoms, emotions and overall quality of life related to the treatment received. Below is the scale that will be used:
| asked in last visit and 1 month after last intervention again at 3 months after last intervention |
| Measure Yourself Medical Outcome Profile ( MYMOP2) | Measure Yourself Medical Outcome Profile (MYMOP2 ) is a 'patient-centred' outcome scale where patients are asked to nominate one or two symptoms (physical or mental) of a specific problem they need assistance with and consider the severity of these symptoms over the last week. Aims to measure the outcomes that the patient considers the most important. The patient chooses one or two symptoms for which they are seeking help and that they consider most important. They also choose an activity of daily living that is limited or prevented by these symptoms. These choices are written down in the patient's own words and the patient scores them for severity over the past week on a seven-point scale. Lastly, wellbeing is scored on a similar scale. On follow-up questionnaires, the wording of the previously chosen symptoms is unchanged. Follow-up questionnaires will be admin | Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention |
| Functional Disability Inventory(FDI) | Functional Disability Inventory (FDI) was developed to measure physical functioning in school-aged children and adolescents. This measure relates to the ability to perform a range of everyday physical activities and has been well-established with different populations. The total FDI score is a sum of all of the items. Clinical reference points were developed to identify 3 categories of disability in pediatric chronic pain:
| Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention |
| Pediatric Migraine Disability Assessment (PedMIDAS) | Pediatric Migraine Disability Assessment (PedMIDAS) was developed to assess migraine disability in pediatric and adolescent patients It has been tested and validated for ages 4 to 18. The score is a simple composite of the total of six questions. If a range is provided, use the high end of the range or ask the family to provide a single number - both methods show equal validity. If the answer is blank or is a phrase (i.e., "few" or "couple"), they need to be asked to provide a number. The PedMIDAS grading scale is as follows:
| Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention |
| Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index (PSQI) We evaluate sleep quality using PSQI. The scale counts 19 items assessing sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Point values of each item in of the seven subscales are summed and then combined as indicated to generate a subscale score. These totals are summed to create the global PSQI score. Scores range from 0-5 indicates good quality of sleep. | Asked in : initial visit , visit 12 , 1 month post last intervention and 3 months after last intervention |
| Number of Analgesic Medications used | Patients will be encouraged to continue with their previous treatments and will not be asked to stop taking any medications in order to participate in this study. However, they will be allowed to reduce the doses or, eventually, to stop the use of analgesic medication under medical supervision. The number and class of analgesics taken will be collected at baseline, at the end of the treatment, and 1 and 3 months after the end of the treatment. The less the Analgesics medications used the Better . | up to 3 months after last intervention |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051271 | Headache Disorders, Secondary |
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| ID | Term |
|---|---|
| D059387 | Sphenopalatine Ganglion Block |
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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