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Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program

D

Danish Headache Center

Status

Completed

Conditions

Trigeminal Neuralgia

Treatments

Other: multidisciplinary management

Study type

Observational

Funder types

Other

Identifiers

NCT03838393
H-1-2012-093

Details and patient eligibility

About

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

Enrollment

186 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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