Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838393
• Other study ID #: H-1-2012-093
• Status: Completed
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Other:
• multidisciplinary management
pharmacological and non.pharmacological treatment (specially trained nurses, psychologists and physiologists)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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