Facial Pain, Glossopharyngeal Neuralgia, Hemifacial Spasm, Neurovascular Conflict, Tic Douloureux, Trigeminal Neuralgia
Conditions
Keywords
Trigeminal Neuralgia, Registry, prospective study, eligibility determination, efficacy, treatment, Follow-Up Studies, indication, microvascular decompression, Jannetta, tic douloureux, hemifacial spasm, neurovascular conflict, glossopharyngeal neuralgia
Brief summary
The aim of the registry is a multicenter, prospective long-term data collection of patients suspected neurovascular conflict and referred for possible microvascular decompression (Jannetta procedure). The registry relies exclusively on routinely collected clinical data, which are gathered in a standardized and privacy-compliant manner as part of everyday clinical practice. By systematically compiling this information across multiple centers, valuable insights into the effectiveness, potential side effects, and long-term outcomes of this surgical treatment can be gained. The registry will serve as a foundation for future scientific analyses and is intended to help answer relevant research questions regarding the treatment of trigeminal neuralgia based on solid evidence.
Interventions
None listed
Sponsors
NeuroResearchOffice at Cantonal Hospital Aarau
Gerrit A Schubert
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* suspected neurovascular conflict * signed consent for further use of routine clinical data as accepted by local regulations
Exclusion criteria
* refusal of further use of routine clinical data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief after surgical treatment | From enrolment to last follow-up 5 yrs after surgery | Efficacy of microvascular decompression surgery, defined by the change in pain as assessed by the patient using the Visual Analog Scale (VAS) from 0 to 100 mm, with higher scores representing worse outcomes. |
| Face specific pain relief after surgical treatment | From enrolment to last follow-up 5 yrs after surgery | Efficacy of microvascular decompression surgery, defined by the change in facial pain and pain interference as assessed by the patient using the Brief Pain Inventory-Facial (BPI-Facial), with numerical scores ranging from 0 to 10, where higher scores represent worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | three months after index surgery | any complications directly attributable to the surgical intervention |
| Need for additional treatment | 5 years after index surgery | rate of patients having to undergo additional surgery / intervention / medication after microvascular decompression |
| Patient satisfaction | 5yrs after index surgery | Perceived benefit of surgery as determined by Patient global impression of change (PGIC) scores. The PGIC is a 7-point, patient-reported scale that captures an individual's overall perception of change in their condition. It ranges from very much improved to very much worse, enabling patients to rate whether they feel their health has improved, remained the same, or declined. |
| Effect of surgical treatment on quality of life | 5 years after index surgery | Efficacy of microvascular decompression surgery as defined by change of Quality of Life Questionaire as measured by EQ-5D-5L. The EQ-5D-5L is a standardized, patient-reported outcome measure that assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from no problems to extreme problems. |
Countries
Germany, Switzerland
Contacts
Primary ContactStefanie Pflugi
Outcome results
None listed