ISRCTN10430251
Completed
N/A
The effect of patient positioning on patient reported outcomes after GON block for primary headache disorder: a multi-centre, four-arm, controlled, prospective randomised trial
Cumbria Partnership NHS Foundation Trust0 sites172 target enrollmentSeptember 4, 2018
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cumbria Partnership NHS Foundation Trust
- Enrollment
- 172
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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:
Outcomes
Primary Outcomes
Not specified
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