Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache

Cervicogenic Headache Clinical Trial

Official title:

Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache: A Prospective, Randomized, Double-blind, Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184197
• Other study ID #: 2004-000724-32
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: March 10, 2017
• Start date: May 2005
• Est. completion date: December 2009

Study information

• Verified date: March 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Headache strictly unilateral without side-shift

• Traits indicating involvement of neck structures, fulfilling at least 2 of the following:

I. Reduced neck range of motion II. Typical headache can be elicited by palpation or pressure on muscles of the occiput or in the neck.

III. Typical headache can be precipitated by certain neck movements or by adopting a certain position of the head.

IV. There is a radiation of pain to the ipsilateral shoulder or arm.

• Positive effect of blockades. (In this study only a blockade of the greater occipital nerve will be applied).

• The condition has lasted for more than 1 year.

• The headache should be present more than 15 days a month, and the frequency should be based on a headache diary filled in the last month before inclusion.

Exclusion Criteria:

• Cervical spinal stenosis, cervical disc herniation, or other neck pathology that should be treated surgically.

• Malignant disorder.

• Rheumatic disorder or other disorders which induces analgesic use.

• other clinically relevant disease (liver, kidney, endocrinological, metabolical, systemic, psychiatric).

• Frequent other headache type that cannot be distinguished from cervicogenic headache.

• Pending or ongoing litigation for head- or neck trauma.

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

Drug:
• Botulinum toxin

• Placebos

Locations

Country	Name	City	State
Norway	Dept. of Neurology and Clinical Neurophysiology, Norwegian Headache Centre	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Linde M, Hagen K, Salvesen Ø, Gravdahl GB, Helde G, Stovner LJ. Onabotulinum toxin A treatment of cervicogenic headache: a randomised, double-blind, placebo-controlled crossover study. Cephalalgia. 2011 May;31(7):797-807. doi: 10.1177/0333102411398402. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days with headache from week 2 after injection to week 7.		8 weeks
Secondary	No. of days until the patient has got > 50% of the pain level he or she had before the injection.		8 weeks
Secondary	No. of drop-outs due to long-lasting improvement after first injection		2 weeks
Secondary	No. of hours with headache from week 2 to week 7		8 weeks
Secondary	Average headache intensity from week 2 to week 7.		8 weeks
Secondary	Headache index (number of hours with headache times the number of pain intensity)		8 weeks
Secondary	Number of days with neck pain from week 2 to week 7.		8 weeks
Secondary	Number of days with shoulder or arm pain from week 2 to week 7.		8 weeks
Secondary	Number of doses with analgesics from week 2 to week 7.		8 weeks
Secondary	Number of days with sick-leave from week 2 to week 7.		8 weeks