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 个研究点目标入组 172 人开始时间: 2018年9月4日最近更新: 2022年4月25日

试验速览

暂无简介。

•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

•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

发起方

Cumbria Partnership NHS Foundation Trust