PARAGON; patient reported outcomes after GON block
Research type
Research Study
Full 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
IRAS ID
248606
Contact name
Jitka Vanderpol
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
Clinicaltrials.gov Identifier
18/SC/0334, 18/SC/0334
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
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. A subset of patients does not respond to currently available prophylaxis and rescue medication. Nerve block medication treatment is offered to these treatment-resistant patients. Greater occipital nerve block (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 optimal method for delivering GON block is to be finalised 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 use a prospective, randomised, multi-centre approach to determine whether the patient’s position straight after injection of the GON block medicine influences the patient-reported outcomes regarding headache symptoms afterwards. A headache-reporting App called Curelator, used by participating patients during the trial period, will allow prospective recording of headaches which may reduce the bias observed with retrospective patient recall of headache episodes.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0334
Date of REC Opinion
19 Jun 2018
REC opinion
Favourable Opinion