Defining Core Outcome Sets in Trigeminal Neuralgia (TRINCOS)

February 3, 2022 updated by: University College, London
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Focus Group
Qualitative research done with a group of patients with TN. Patients will describe their experience of living with the disease and what outcomes of treatment they consider to be important.
Other: Observational
Observational
Delphi survey
Group of relevant stakeholders - patients, clinicians and researchers will rate the outcomes of treatment in a 3 round Delphi survey.
Other: Observational
Observational
Consensus meeting
Group of relevant stakeholders - patients, clinicians and researchers will rate the outcomes of treatment and finalise the COS for Trigeminal Neuralgia.
Other: Observational
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Define the trigeminal neuralgia core outcome set
Time Frame: 2020-2022
2020-2022

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify the instruments to use in the core outcome set
Time Frame: 2020-2022
2020-2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Rosetrees Trust

Investigators

  • Principal Investigator: Joanna Zakrzweska, Professor, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/0901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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