Headache disorder, including migraine, occipital neuralgia, cluster headache and trigeminal autonomic cephalgia Nervous System Diseases
Conditions
Interventions
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 t
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
Sponsors
Cumbria Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Under the age of 18 years 2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity 3. Any condition that precludes patients from receiving GON block, including: 3.1. Disorders associated with excessive bleeding, coagulation abnormalities or any other significant haematological condition (e.g. Factor V Leiden, haemophilia, thrombocytopaenia). 3.2. Known acute or previous base of skull fracture 3.3. Allergy or hypersensitivity to any active ingredients or excipients used for GON block 4. Patients who are participating in another interventional research study involving an investigational product related to their headache disorder 5. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives 6. Subjects who have received greater occipital nerve blocks (both GON or Botox) in the last 6 months, or are still headache-free following an intervention 7. For randomisation after baseline period: 7.1. Less than two headache episodes in baseline 30 day data collection period 7.2. Curelator App used < 90% of 30 day baseline diary period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
England, United Kingdom
Outcome results
None listed