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Clinical Trials/ISRCTN10430251
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.

Registry
who.int
Start Date
September 4, 2018
End Date
March 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Cumbria Partnership NHS Foundation Trust

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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