Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program

Study Overview
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Brief Summary
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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

Official Title
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Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program - a Two-year Prospective Real-life Study

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Other: multidisciplinary management


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: recordings of the intensity of pain at enrolment of the programme (baseline recording), a two-year assessment (end-point recording), recording of effect and side-effects of drug treatment (at baseline and endpoint). The exclusion criteria initiation of medical treatment at the DHC before May 2012, neurosurgical treatment of TN within the two-year follow-up incomplete two-year follow-up
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: multidisciplinary management|pharmacological and non.pharmacological treatment (specially trained nurses, psychologists and physiologists)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in overall burden of pain NRS over a two-year period | Defined as a good outcome, i.e number of patients who had a reduction of minimum 50% on the NRS two years after enrolment in the management program compared with baseline | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No changes of the overall burden of pain NRS over the two-year follow-up period | Defined as poor outcome, i.e number of patients who had a no reduction the NRS two years after enrolment in the management program compared with baseline | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multidisciplinary management, real-life study