DRKS00018776CompletedPhase 2
Efficacy of acupuncture treatments on frequency and intensity of pain attacks in patients with idiopathic or classic trigeminal neuralgia - ACUTRIG ACUpuncture in TRIGeminal neuralgia
Charité Campus Charité Mitte0 sites20 target enrollmentStarted: September 6, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (—)
- Sex
- All
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
- •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
Investigators
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