Trigeminal neuralgia G50.0
Conditions
Interventions
Group 1: acupuncture plus routine care
Group 2: routine care
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of idiopathic or classical trigeminal neuralgia 2. Age between 18- 85yrs 3. At least 3 attacks per day, with an intensity of at least 4 on a NRS, on at least 4 days per week 4. Stable (unchanged dose since 4 weeks) prophylactic medication (e.g.: carbamazepine, oxcarbazepine, baclofen, phenytoin, gabapentin, lamotrigine etc.) 5. Stable concomitant medication with possible influence on trigeminal neuralgia (antidepressants, duloxetine) 6. Patient is ready to take part in randomization process, and willing to fill out diaries 7. Patient provided written and oral consent to participation in study
Exclusion criteria
Exclusion criteria: 1. Symptomatic or secondary trigeminal neuralgia (due to Multiple Sclerosis, tumors etc.) or additional SUNCT, SUNA or paroxysmal hemicranias or cluster headaches 2. Use of opioids or opiates before inclusion into study 3. Frequent or chronic THC or Cannabis use before inclusion into study or during study 4. Psychotherapy during three months before study or planned during study participation 5. Additional complementary or alternative treatment 4 weeks before inclusion into study or during study participation new 5a: acupuncture in the 12 weeks before study onset. 6. For female patients pregnancy or breast- feeding 7. Somatic or mental illness that prevent from participation in the study (e.g. bleeding disorders, oral anticoagulation, psychosis) 8. Alcohol or drug abuse 9. Missing knowledge of German language 10. Participation in other interventional studies 11. Ongoing incapacity pension process 12. Planned rehabilitation during study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of pain attacks/d using diaries in week -1 - week 8, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of pain attacks/d using diaries in week 20 and 52 mean intensity of pain attacks/d measured by a numeric rating scale NRS by using diaries in week -1 - week 8, week 12, 20 and 52 • Changes in specific medication using diaries in week -1 - week 8, week 12, 20 and 52 • Emotional component of pain measured by the German Schmerzempfindungsskala (SES) in week 8, week 12, 20 and 52 • Penn-Facial-Pain Scale (Penn- FPS) questionnaire in week 8, 12, 20 and 52 • Barrow Neurological Institute Pain Intensity score (BNI) in week 8, 12, 20 and 52 • Quality of Life measured by the Short-Form 12 (SF-12) in week 8, 12, 20 and 52 • Hospital Anxiety and Depression Scale (HADS-D) in week 8, 12, 20 and 52 • Patient Global Impression of Change (PGIC) in week 8, 12, 20 and 52 • Safety / adverse event reporting throughout the study | — |
Countries
Germany
Contacts
Public ContactMargit Cree
Institut für Sozialmedizin, Epidemiologieund GesundheitsökonomieFachbereich komplementäre & integrative Medizin
Outcome results
None listed