Patient reported outcomes after GON block [study]

Jonker, Leon (2018) Patient reported outcomes after GON block [study]. ISRCTN Registry . (Unpublished)

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Official URL: https://doi.org/10.1186/isrctn10430251

Abstract

Background and study aims:
Primary headache disorders, including migraine, cluster headache, and occipital neuralgia, are some of the most debilitating conditions that impact negatively on patients themselves and the wider economy. Some patients do not respond to currently available prophylaxis (preventative) and rescue medication. Nerve block medication treatment is offered to these treatment-resistant patients. Greater occipital nerve (GON) block is an established nerve block procedure that has a favourable safety profile and is cost-effective – the active ingredients used are a mix of local anaesthetic agent and steroid. The exact effectiveness and the best method for delivering GON block is not yet known due to a relative lack of evidence from gold-standard randomised controlled trials and variety in the applied GON block procedure. Initial pilot data on GON block patients, and related evidence from use of anaesthetics in dentistry, suggests that lying a patient down for ten minutes after the procedure enhances the effectiveness of the GON block and thereby leads to an increase in the achieved headache-free period. This present study seeks to determine whether the patient’s position straight after injection of the GON block medicine influences headache symptoms afterwards. A headache-reporting App called Curelator, used by participating patients during the trial, may reduce the bias observed with retrospective patient recall of headache episodes.

Who can participate?
Patients aged 18 or older with primary headache disorder

What does the study involve?
Participants 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). They use the app for a total of 120 days (30 days before GON block, and up 90 days after the GON block). Participants complete up to three questionnaires related to headache disorder and how it impacts on their daily living. At their next appointment for their GON block, they are randomly allocated to one of two patient positions (sitting or lying down) and are asked how painful they thought the GON block procedure was. During the follow-up period the participants are asked to complete the same questionnaires as before at 30 and 90 days after the GON block appointment. In addition they are asked about the relief they have had from the GON block procedure and what they think of the Curelator app. Participants do not have to visit the neurology clinic more often than normal. All follow-up visits can be done remotely, via e-mail, phone or post.

What are the possible benefits and risks of participating?
This study aims to find out if one patient position is more effective than the other in minimising headache-related pain (frequency, intensity etc). At the moment there is some indication that one position is better than the other. However, this has not yet been proven and established, and this study is aimed to assess this. This trial will also assess if the use of a headache-recording app is useful to check a patient’s headache frequency. The Curelator headache app will be provided to participants free of charge and normally retails at about £48. Participants cannot claim payments, reimbursement of expenses or any other benefits or incentives for taking part in this study. There is no personal safety risk anticipated regarding taking part in this study. There is no risk anticipated with sitting up or lying down for 10 minutes after the GON block procedure. Like with any invasive procedure, the GON block procedure itself (which is not classed as a trial intervention) carries risks such as localised bleeding and localised hair loss. If patients decide to take part in the study, and their Neurologist, nurse or the research team learns of important new information that might affect their desire to remain in the study, they will tell the participants as soon as possible. Appropriate precautions are in place to ensure participants’ medical and personal information is kept safe.

Where is the study run from?
1. Cumbria Partnership NHS Foundation Trust (UK)
2. City Hospitals NHS Sunderland Foundation Trust (UK)
3. Hull and East Yorkshire Hospitals NHS Trust (UK)
4. Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
August 2018 to November 2019

Who is funding the study?
Curelator, Inc.

Who is the main contact?
Dr Leon Jonker leon.jonker@nihr.ac.uk

Scientific title:
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

Acronym:
PARAGON

Item Type: Article
Journal or Publication Title: ISRCTN Registry
Publisher: BioMed Central / Springer Nature
Departments: Health and Medical Sciences
Additional Information: 05/10/2018: Internal review. 04/09/2018: Uploaded protocol Version 2, 23 August 2018 (not peer reviewed). This is a trial that has been prospectively registered. ISRCTN ID 10430251. Protocol/serial number 38836.
Depositing User: Insight Administrator
SWORD Depositor: Insight Administrator
Date Deposited: 18 Oct 2018 13:34
Last Modified: 15 Nov 2018 16:34
URI: http://insight.cumbria.ac.uk/id/eprint/4088

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