Efficacy of acupuncture treatments on frequency and intensity of pain attacks in patients with idiopathic or classic trigeminal neuralgia
- Conditions
- Trigeminal neuralgiaG50.0
- Registration Number
- DRKS00018776
- Lead Sponsor
- Charité Campus Charité Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of pain attacks/d using diaries in week -1 - week 8, week 12
- Secondary Outcome Measures
Name Time Method •Number of pain attacks/d using diaries in week 20 and 52<br>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<br>•<br>Changes in specific medication using diaries in week -1 - week 8, week 12, 20 and 52<br>•Emotional component of pain measured by the German Schmerzempfindungsskala (SES) in week 8, week 12, 20 and 52<br>•Penn-Facial-Pain Scale (Penn- FPS) questionnaire in week 8, 12, 20 and 52<br>•Barrow Neurological Institute Pain Intensity score (BNI) in week 8, 12, 20 and 52<br>•Quality of Life measured by the Short-Form 12 (SF-12) in week 8, 12, 20 and 52<br>•Hospital Anxiety and Depression Scale (HADS-D) in week 8, 12, 20 and 52<br>•Patient Global Impression of Change (PGIC) in week 8, 12, 20 and 52<br>•Safety / adverse event reporting throughout the study