Lucht via de neus als behandeling voor medicatie-afhankelijke hoofdpijn ten gevolge van overgebruik van triptanen

Rationale:

Medication overuse headache (MOH) is a disorder that results from the overuse of analgesics, triptans or other acute headache medication. Patients overusing triptans are almost always patients with migraine as their primary headache. There is general agreement that the only treatment of MOH is withdrawal of the overused medication (eg detoxification). In general, no other analgesics (rescue medication) are permitted during detoxification, as subjects tend to risk overusing this rescue medication also. Discontinuation of the overused headache medication often results in the development of withdrawal headache, often associated with nausea, vomiting, photophobia, phonophobia, sleep disturbances, restlessness and nervousness. In general and especially in the case of triptan overuse, the first week of detoxification is most difficult, resulting in the frequent failure of the detoxification process and subjects continuing to overuse their medication. Today no alternative treatment for withdrawal headache during triptan detoxification exists.



Objective:

The aim of this study is to investigate the effect of the RhinoChill nasal cavity Cooling System (RhinoChill System) on severity and frequency of withdrawal headache and associated symptoms in the first 7 days during standard care treatment for detoxification of triptan-overuse headache as compared to sham treatment during standard care treatment.



Study Design:

A prospective, multicenter, double-blinded, sham-controlled, randomized controlled trial.



Study population:

Adult patients with migraine and triptan-overuse headache who are admitted for detoxification due to overuse of triptan medication.



Intervention:

In-hospital application with up to 10 minutes of nasal cavity cooling per treatment with the RhinoChill System (with further treatments every 2 hours, if required, up to a maximum of 4 treatments per 24 hours and maximum of 24 treatments in 7 days), along with standard care treatment versus sham-RhinoChill (only air without cooling) with standard care treatment.



Primary end point:

Number of hours with severe or moderate headache in the first 7 days.



Hypothesis:

The hypothesis we propose is that the application of RhinoChill nasal cavity cooling will provide effective relief of withdrawal headache and associated symptoms, in patients with triptan-overuse headache in the first week of detoxification.

Medication overuse headache (MOH) is a disorder that results from the overuse of analgesics, triptans or other acute headache medication. Patients overusing triptans are almost always patients with migraine as their primary headache. There is general agreement that the only treatment of MOH is withdrawal of the overused medication (eg detoxification).



The aim of this study is to investigate the effect of the RhinoChill nasal cavity Cooling System (RhinoChill System) on severity and frequency of withdrawal headache and associated symptoms in the first 7 days during standard care treatment for detoxification of triptan-overuse headache as compared to sham treatment during standard care treatment.



The hypothesis we propose is that the application of RhinoChill nasal cavity cooling will provide effective relief of a withdrawal headache and associated symptoms, in patients with triptan-overuse headache in the first week of detoxification.

Primary outcome: 1 week

Secondary outcomes: 1 week and 8 weeks

In-hospital application with up to 10 minutes of nasal cavity cooling per treatment with the RhinoChill System (with further treatments every 2 hours, if required, up to a maximum of 4 treatments per 24 hours and maximum of 24 treatments in 7 days), along with standard care treatment versus sham-RhinoChill (only air without cooling) with standard care treatment.