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OpenTrials
Completed

NCT Number: NCT03838393

Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program

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

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multidisciplinary management

Other

pharmacological and non.pharmacological treatment (specially trained nurses, psychologists and physiologists)

Primary outcomes

  1. change in overall burden of pain NRS over a two-year period

    Time frame: 2 years

    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

Secondary outcomes

  1. No changes of the overall burden of pain NRS over the two-year follow-up period

    Time frame: 2 years

    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

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2019
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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