Medication-overuse headache triptan-overuse headache
Conditions
Sponsors
HagaZiekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: A. Age 18 * and * 70 years of age B. Migraine diagnosis established before by neurologist C. Diagnosis of triptan overuse headache according to the diagnostic criteria of the International Headache Society, 3rd edition (beta version) D. Patient suitable for admission for an in-patient detoxification programme E. Able to attend a short training session on the practical use of the RhinoChill device and agrees to only use the device as instructed and as laid out in the official instructions for use.
Exclusion criteria
Exclusion criteria: A. 70 years of age B. Only overuse of simple analgesics, defined as the use of simple analgesics (acetaminophen, NSAID*s) in *15 days / month. C. Change of preventive migraine medication in the previous 3 months D. Abuse of alcohol of other elicit drugs (DSM criteria) E. Known oxygen dependency to maintain SaO2 >95% F. Currently uncontrolled hypertension with Systolic BP > 160 mmHg and diastolic BP > 95mmHg on baseline assessment G. Marked nasal septal deviation, recurrent epistaxis or chronic rhino-sinusitis H. Intranasal obstruction preventing full insertion of nasal catheter I. Known acute base of skull fracture or facial trauma (in previous 2 months) J. Concurrent sinus/intranasal surgery (in previous 2 months or next 2 months) K. Medical history of thrombocytopenia L. Previous stroke or myocardial infarction M. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of hours with severe or moderate headache in the first 7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Headache response 1 hour, 2 hours and 24 hours after treatment. - Time to meaningful relief from headache after treatment. - Time to freedom from pain after treatment. - Number of hours with withdrawal symptoms in the first 7 days: nausea, vomiting, photophobia, phonophobia, restlessness. - Total amount of days of hospitalization. - Patient satisfaction. - Reduction in number of headache days / month with moderate or severe intensity - Units of used escape medication during initial 7 days and remaining 7 weeks period. - Reduction in number of migraine days / month after 2 months. - Reduction in number of migraine episodes / month after 2 months. - Conversion rate from subjects with chronic migraine to episodic migraine. - Percentage successful complete withdrawal of triptans during study months. - Conversion rate from subjects using > 10 days triptans per month to | — |
Countries
Netherlands
Outcome results
None listed