NCT04272385

Defining Core Outcome Sets in Trigeminal Neuralgia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 32 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
OTHER	Observational	Observational

Timeline

• Start date: 2020-03-02
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-02-17
• Last updated: 2022-02-21

Locations

1 site across 1 country: United Kingdom