The aim of this study is to investigate the effect of the intranasal cooling (RhinoChill System) on the severity and frequency of withdrawal headache and associated symptoms in the first 7 days during standard care treatment for detoxification of…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of hours with severe or moderate headache in the first 7 days.
Secondary outcome
- 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 < 10 days
per month triptan use per month.
Background summary
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 and
frequent overuse triptans (specific migraine medication). 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. 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, in the case of
triptan overuse, the first week of detoxification is most difficult. If
detoxofication at home is not possible patients can be admitted to the
hospital. The severtiy of withdrawal symptoms often results in failure of the
detoxification process and subjects continuing to overuse their medication.
Today no alternative treatment for withdrawal headache during triptan
detoxification exists.
Study objective
The aim of this study is to investigate the effect of the intranasal cooling
(RhinoChill System) on the 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.
Study design
A prospective, double-blinded, sham-controlled, randomized controlled trial.
Intervention
Application of intranasal cooling with the RhinoChill System: up to 10 minutes
of nasal cavity cooling per treatment 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.
Study burden and risks
Before inclusion patients are asked to fill in a headache diary and a
questionnaire. During the study patients are asked to fill in diaries. During
the study patients will visit the outpatient clinical 2 times, standard care is
visiting the outpatient clinical for 1 or 2 times (so when participating in the
study possible 1 visit extra (besides standard care) will be asked). The device
has been CE marked. Intranasal cooling can result in a few (minor) side
effects, for example nasal discomfort, runny nose, sneezing, (mild) epistaxis,
strange tase or smell and dry eyes. All side effects are minor in nature and
resolve spontaneously after discontinuation or completion of the treatment.
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Listed location countries
Age
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
A. < 18 and > 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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60091.098.16 |
| OMON | NL-OMON24899 |