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


- candidate number27246
- NTR NumberNTR6452
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mei-2017
- Secondary IDsNL60091.098.16 
- Public TitleLucht via de neus als behandeling voor medicatie-afhankelijke hoofdpijn ten gevolge van overgebruik van triptanen
- Scientific TitleCOOLHEAD3: Nasal cavity evaporative COOLing for the symptomatic relief of withdrawal HEADache and associated symptoms during triptan-overuse detoxification
- ACRONYM
- hypothesisMedication 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.
- Healt Condition(s) or Problem(s) studiedMigraine, Headache
- Inclusion criteriaA. 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 criteriaA. < 18 and > 70 years of age.
B. Only overuse of simple analgesics, defined as the use of simple analgesics (acetaminophen, NSAID°Įs) 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-mei-2017
- planned closingdate31-dec-2018
- Target number of participants80
- InterventionsIn-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 outcomeNumber of hours with severe or moderate headache in the first 7 days.
Headache will be scored on a four-point scale: 0 = no headache, 1 = mild headache, 2 = moderate headache and 3 = severe headache.
- Secondary outcome- Headache response, defined as improvement of pain from severe/moderate to mild/none immediately following treatment (10 minutes), at 1 hour, 2 hours, and 24 hours following treatment. When the RhinoChill System is used before 24 hours because of recurrence of the pain this will be scored as °ģnot applicable°Į at 24 hours.

- Time to meaningful relief from withdrawal headache, defined as total minutes after beginning of treatment with RhinoChill System to effect (mild or no headache)

- Time to freedom from pain, defined as total minutes after beginning of treatment with RhinoChill System to effect (no headache)

- Number of hours with withdrawal symptoms in the first 7 days:
o Nausea, scored as: none, mild, moderate or severe o Vomiting, scored as: none, mild, moderate or severe o Photophobia, scored as: none, mild, moderate or severe o Phonophobia, scored as: none, mild, moderate or severe o Restlessness , scored as: none, mild, moderate or severe

- Total amount of days of hospitalization

- Patient satisfaction of the use of the RhinoChill System to manage pain and symptoms of medication overuse withdrawal headache. This will be scored with a Likert scale:
o I am very satisfied by the use of the RhinoChill System to manage pain and associated symptoms, such as nausea and vomiting, photophobia, phonophobia and restlessness, during the first 7 days of withdrawal of triptan overuse headache: Strongly disagree, disagree, neither agree nor disagree, agree, strongly agree.

- 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. A migraine day is defined as a day with migraine according to diagnostic criteria of the International Headache Society, 3rd edition (beta version), table 1.

- Reduction in number of migraine episodes / month.

- Conversion rate from subjects with chronic migraine (°› 15 days / month) to episodic migraine (< 15 days / month).

- Percentage successful complete withdrawal of triptans during study months, defined as no use of triptans during the detoxification period.

- Conversion rate from subjects using > 10 days triptans to < 10 days triptan use per month.
- TimepointsPrimary outcome: 1 week
Secondary outcomes: 1 week and 8 weeks
- Trial web sitehttp://neurologie-denhaag.nl/polikliniek/coolhead3.html
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD H. Koppen
- CONTACT for SCIENTIFIC QUERIESMD H. Koppen
- Sponsor/Initiator H. Koppen, HagaZiekenhuis
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD18-mei-2017 - 1-jul-2017


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