Clinical trial NCT03838393: Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program
Official title: Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program - a Two-year Prospective Real-life Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia
Keywords: multidisciplinary management
real-life study
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 186
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The diagnostic criteria used in this study were the beta version of the 3rd edition of the International Classification of Headache Disorders (ICHD-3-beta). Until the publication of IHCD-3-beta, ICHD 2 criteria were used. According to the ICHD-3 classification, this study included patients with both idiopathic and classical TN; in this paper termed primary TNThe number of patients enrolled in the inclusion period determined the sample size.

Brief summary: Background: Prognosis of medically treated trigeminal neuralgia patients is assumed to be poor, but the evidence is lacking. Thus, prospective real-life studies of medical management of trigeminal neuralgia are warranted.

Methods: Observational study. Patients were consecutively enrolled in a structured management program at a specialist centre for facial pain. Optimisation of medical treatment, physiotherapy, psychotherapy, and advice from trained nurses, were parts of the program. Medically intractable patients were referred for neurosurgery. Data-collection was prospective using standardised schemes and patient surveys. The aim was to describe the two-year outcome of medical treatment at the specialist centre. The primary outcome was a 50% reduction in the overall burden of pain according to a Numerical Rating Scale (NRS) after two years.

This study aimed to provide evidence concerning the real-life efficacy of medical management of trigeminal neuralgia (TN) when directed by specialists. The investigatgors hypothesised that the two-year prognosis in a group of medically managed TN patients enrolled in a structured multidisciplinary management program was favourable, defined as a 50 % reduction of the overall burden of pain over a two-year period


Eligibility criteria: Inclusion criteria:

1. recordings of the intensity of pain at enrolment of the programme (baseline recording),
2. a two-year assessment (end-point recording),
3. recording of effect and side-effects of drug treatment (at baseline and endpoint).

The exclusion criteria

1. initiation of medical treatment at the DHC before May 2012,
2. neurosurgical treatment of TN within the two-year follow-up
3. incomplete two-year follow-up

Primary outcomes:
measure: change in overall burden of pain NRS over a two-year period
timeFrame: 2 years
Secondary outcomes:
measure: No changes of the overall burden of pain NRS over the two-year follow-up period
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Heinskou TB, Maarbjerg S, Wolfram F, Rochat P, Brennum J, Olesen J, Bendtsen L. Favourable prognosis of trigeminal neuralgia when enrolled in a multidisciplinary management program - a two-year prospective real-life study. J Headache Pain. 2019 Mar 4;20(1):23. doi: 10.1186/s10194-019-0973-4.