Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program

NCT03838393 | Completed

• 1 other identifier: H-1-2012-093
• Study Type: observational
• Target: 186
• Locations: 0 countries
• Sites: N/A

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

Conditions

Trigeminal Neuralgia

Keywords

multidisciplinary management; real-life study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 years

Interventions

multidisciplinary management OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The diagnostic criteria used in this study were the beta version of the 3rd edition of the International Classification of Headache Disorders (ICHD-3-beta). Until the publication of IHCD-3-beta, ICHD 2 criteria were used. According to the ICHD-3 classification, this study included patients with both idiopathic and classical TN; in this paper termed primary TNThe number of patients enrolled in the inclusion period determined the sample size.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Related Publications (1)

• Heinskou TB, Maarbjerg S, Wolfram F, Rochat P, Brennum J, Olesen J, Bendtsen L. Favourable prognosis of trigeminal neuralgia when enrolled in a multidisciplinary management program - a two-year prospective real-life study. J Headache Pain. 2019 Mar 4;20(1):23. doi: 10.1186/s10194-019-0973-4.

  PMID: 30832577 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 12, 2019
• Study Start: May 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share