Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184197
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2005-09-12
Brief Title:
Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache A Prospective Randomized Double-blind Cross-over Study
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effect and side-effects of injections with botulinum toxin in neck muscles in cervicogenic headache compared to injections with sodium water
Detailed Description:
Cervicogenic headache is a unilateral headache stemming from the neck Usually there are no pathological findings on x-ray or MRI of the neck It is supposed that pain may stem from various structures in the upper part of the cervical spine Regardless of the source it is often believed that the neck muscles may be involved in the pain generation either primarily or secondarily
Treatment of cervicogenic headache is often difficult The effect of drugs is usually limited Various surgical techniques such as radiofrequency generation of the facet joints in the neck have been tried but with little success 4
Botulinum toxin injection in muscles have for several years been used in conditions with pathologically increased muscle activity such as spasticity and dystonias Gradually it has also been used in many pain conditions among them headaches One case history 5 and a randomized placebo controlled double-blind study 6 have shown effect in cervicogenic headache The latter study had some methodological weaknesses since it was small only 26 patients and the placebo group had prior to treatment only half as much pain as the group receiving botulinum toxin treatment In addition pain was not registered daily but only before prior treatment and after 3 or 4 weeks A review considers the documentation on treatment with botulinum toxin in idiopathic and cervicogenic headaches to be inconclusive 7
In our Department we have tried this treatment on a few patients with typical cervicogenic headache with excellent effect and without side-effects Therefore it would be of considerable interest to perform a larger study with good scientific quality and a higher statistical power than the above-mentioned one
As the basis for our study we would adopt a conservative hypothesis H0 Botox injections in cervical muscles is not superior to placebo in alleviating pain in unilateral cervicogenic headache
Treatment of cervicogenic headache is often difficult The effect of drugs is usually limited Various surgical techniques such as radiofrequency generation of the facet joints in the neck have been tried but with little success 4
Botulinum toxin injection in muscles have for several years been used in conditions with pathologically increased muscle activity such as spasticity and dystonias Gradually it has also been used in many pain conditions among them headaches One case history 5 and a randomized placebo controlled double-blind study 6 have shown effect in cervicogenic headache The latter study had some methodological weaknesses since it was small only 26 patients and the placebo group had prior to treatment only half as much pain as the group receiving botulinum toxin treatment In addition pain was not registered daily but only before prior treatment and after 3 or 4 weeks A review considers the documentation on treatment with botulinum toxin in idiopathic and cervicogenic headaches to be inconclusive 7
In our Department we have tried this treatment on a few patients with typical cervicogenic headache with excellent effect and without side-effects Therefore it would be of considerable interest to perform a larger study with good scientific quality and a higher statistical power than the above-mentioned one
As the basis for our study we would adopt a conservative hypothesis H0 Botox injections in cervical muscles is not superior to placebo in alleviating pain in unilateral cervicogenic headache
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None