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Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03838393
Enrollment
186
Registered
2019-02-12
Start date
2012-05-31
Completion date
2015-12-31
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

Keywords

multidisciplinary management, real-life study

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

Interventions

OTHERmultidisciplinary management

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

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in overall burden of pain NRS over a two-year period2 yearsDefined 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

MeasureTime frameDescription
No changes of the overall burden of pain NRS over the two-year follow-up period2 yearsDefined 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026