Clinical trial NCT04272385: Defining Core Outcome Sets in Trigeminal Neuralgia
Official title: Defining Core Outcome Sets in Trigeminal Neuralgia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trigeminal Neuralgia
Keywords: trigeminal neuralgia
treatment outcomes
patient reported outcome measures
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Rosetrees Trust
First posted: 2020-02-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with trigeminal neuralgia and are currently receiving treatment (medical or surgical). Clinicians and researchers working in the field.

Brief summary: The aim of this study is to determine what patients with trigeminal neuralgia (TN), clinicians and researchers in the field, consider to be the most important outcomes to be expected after undergoing treatment for trigeminal neuralgia and how this could be measured in all studies relating to this condition. This would enable different treatments to be compared using the same standards.

Detailed description: Trigeminal Neuralgia (TN) is a rare chronic condition that causes agonizing, unpredictable, short-lasting electric shock-like one-sided facial pain and is commonly provoked by triggers such as light touch. This debilitating chronic pain disorder has a significant impact on the quality of life of patients with increased risk of depression and suicide. The current varied outcome measures make it difficult for patients to make decisions about choice of treatments which was highlighted in a study among 156 United Kingdom (UK) patients with TN who completed an adapted time-trade - off utility measure to ascertain how they valued the potential outcomes from various surgical and medical treatments.

Patients can be managed with a range of anticonvulsants or by several types of neurosurgical interventions. To successfully compare the effectiveness and tolerability of various treatment options data is needed from well designed and conducted randomised controlled trials (RCTs) and prospective cohorts which use the same outcome measures. Apart from pain relief only a handful of other outcome measures have been used. It has to date not been possible to compare medical versus neurosurgical treatments and yet this is one of the most frequently asked patient questions. The impact of complications on ability to return to normal activities and improvement in mental health needs to be determined. The development and implementation of Core Outcome Sets (COS) and measures in clinical practice across the UK and in future trials would allow standardised outcome data, thereby facilitating meta-analysis and thus clinical decision-making.

Eligibility criteria: Inclusion Criteria for the focus groups:

* Adult patients (\>18ys) diagnosed with trigeminal neuralgia
* Willing to attend a focus group meeting
* Able to give informed consent
* Undergoing management for trigeminal neuralgia

Exclusion Criteria:

* Unable to attend a focus group meeting
* Insufficient English to take part in a group discussion
* Unable to take part in discussions

Inclusion Criteria for the Delphi survey:

* Adult patients (\>18ys) diagnosed with trigeminal neuralgia
* Clinicians working in the field of Trigeminal Neuralgia

  * Researchers working in the field of Trigeminal Neuralgia
  * Willing to complete a 3 round Delphi survey
* Able to give informed consent

Inclusion Criteria for the online consensus meeting:

* Adult patients (\>18ys) diagnosed with trigeminal neuralgia
* Clinicians working in the field of Trigeminal Neuralgia

  * Researchers working in the field of Trigeminal Neuralgia
  * Able to join an online meeting
  * Have internet access
  * Willing to participate in a discussion with others about the important treatment outcomes in Trigeminal Neuralgia
* Able to give informed consent

Primary outcomes:
measure: Define the trigeminal neuralgia core outcome set
timeFrame: 2020-2022
Secondary outcomes:
measure: Identify the instruments to use in the core outcome set
timeFrame: 2020-2022
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal National ENT and Eastman Dental Hospitals
Study officials:
affiliation: University College, London
name: Joanna Zakrzweska, Professor
role: PRINCIPAL_INVESTIGATOR
References: