Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache: A Prospective, Randomized, Double-blind, Cross-over Study|
- Number of days with headache from week 2 after injection to week 7. [ Time Frame: 8 weeks ]
- No. of days until the patient has got > 50% of the pain level he or she had before the injection. [ Time Frame: 8 weeks ]
- No. of drop-outs due to long-lasting improvement after first injection [ Time Frame: 2 weeks ]
- No. of hours with headache from week 2 to week 7 [ Time Frame: 8 weeks ]
- Average headache intensity from week 2 to week 7. [ Time Frame: 8 weeks ]
- Headache index (number of hours with headache times the number of pain intensity) [ Time Frame: 8 weeks ]
- Number of days with neck pain from week 2 to week 7. [ Time Frame: 8 weeks ]
- Number of days with shoulder or arm pain from week 2 to week 7. [ Time Frame: 8 weeks ]
- Number of doses with analgesics from week 2 to week 7. [ Time Frame: 8 weeks ]
- Number of days with sick-leave from week 2 to week 7. [ Time Frame: 8 weeks ]
|Actual Study Start Date:||May 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Experimental: Botox||Drug: Botulinum toxin|
|Placebo Comparator: placebo||Drug: Placebos|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184197
|Dept. of Neurology and Clinical Neurophysiology, Norwegian Headache Centre|
|Trondheim, Norway, 7006|
|Principal Investigator:||Lars Jacob Stovner, professor||Dept. of Neurology and Clinical Neurophysiology|