Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2018
INTERVENTION: The patient will first be approached about the study during their clinic visit with the neurologist where it will also be discussed whether the patient is suitable for receiving GON block. If indeed they are listed for GON block a few more checks will be made to see if they are eligible to take part in the PARAGON study. For example, one requirement is that they have access to a smartphone, computer or tablet to use an app to record their headaches. When in the study they are asked to use the app daily to record: any headache(s) experienced, and if so what the characteristics of the headache were (length, intensity, etc). Therefore, they will use the App for a total of 120 days max (30 days before GON block, and up 90 days post‐GON block). Once written informed consent has been obtained from the patient, they will be asked about a few baseline items, such as age, sex, height, weight, and some information about their headache disorder diagnosis. They will also be asked to complete up to three questionnaires related to headache disorder and how it impacts on their daily living (HIT‐6, MIDAS and MSQ; the latter for migraine patients only). At their next appointment for their GON block, participants will be given single treatment unilateral or bilateral GON block, inserting a 22‐23 gauge needle, using dose of Lidocaine 2% (20mg) with Depo‐Medrone (80mg) in 2 ml vial, injected close to GON output (1/3 of distance between external protuberance and mastoid process). The intervention is as follows: directly following conclusion of the GON block procedure the patient will either: A. Remain seated vertical (sitting) B. Lie horizontally in a supine position for 10 minutes (with head rested on pillow at approximately 30 degree angle), measured with stopwatch Please note that they will only be randomised if they have completed the Curelator App daily on at least 90% of days in a 30 days period running up to the GON block appointment. During the follow‐up period the part CONDITION: Specialty: Neurological Disorders, Primary sub‐specialty: Other; Health Category: Neurological; Disease/Condition: Episodic and paroxysmal disorders ; Nervous System Diseases PRIMARY OUTCOME: RELIEF (headache relief) patient‐reported outcome score at 90 days post‐GON block; the score will also be recorded at 30 days post‐GON block INCLUSION CRITERIA: 1. Diagnosis fulfilling IHS criteria for primary headache disorder, which includes: 2. For migraine cohort: 2.1. Episodic or chronic migraine 3. For non‐migraine cohort: 3.1. Occipital neuralgia 3.2. Cluster headache 3.3. Trigeminal autonomic cephalgia (TAC) 3.4. Non‐specified or other primary headache disorder 4. Deemed eligible for GON block procedure as determined by treating neurology team 5. Aged 18 or older 6. Mental capacity to give written informed consent SECONDARY OUTCOME: 1. Headache‐free period post‐GON block in days (up to 90 days post‐GON block); 2. Average monthly headache days (in 30 days before GON block and up to 90 days post‐GON block); 3. Severity of headache (severe, moderate, mild, none; (in 30 days before GON block and 30/90 days post‐GON block); 4. Headache characteristics (in 30 days before GON block and 30/90 days post‐GON block), including aura, photophobia; 5. Average length of each headache episode in hours (in 30 days before GON block and 30/90 days post‐GON block); 6. Impact of headache disorder on quality of life (in 30 days before GON block and 30/90 days post‐GON block) using HIT‐6, modified MIDAS, MSQ validated questionnaires (latter for migraineurs only); 7. Prophylactic and/or rescue medication use: total cost of medicine use (in 30 days before GON block and 30/90 days post‐GON block), using British National Formulary as source for costs; 8. Adverse event reporting by participants (at 30 days post‐GON block)
Epistemonikos ID: e175a3fc82c52b530c21dda8f84389576f6805c4
First added on: Aug 24, 2024