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Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184197
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Cervicogenic Headache Drug: Botulinum toxin Drug: Placebos Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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
Actual Study Start Date : May 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Botox Drug: Botulinum toxin
Placebo Comparator: placebo Drug: Placebos

Primary Outcome Measures :
  1. Number of days with headache from week 2 after injection to week 7. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. No. of days until the patient has got > 50% of the pain level he or she had before the injection. [ Time Frame: 8 weeks ]
  2. No. of drop-outs due to long-lasting improvement after first injection [ Time Frame: 2 weeks ]
  3. No. of hours with headache from week 2 to week 7 [ Time Frame: 8 weeks ]
  4. Average headache intensity from week 2 to week 7. [ Time Frame: 8 weeks ]
  5. Headache index (number of hours with headache times the number of pain intensity) [ Time Frame: 8 weeks ]
  6. Number of days with neck pain from week 2 to week 7. [ Time Frame: 8 weeks ]
  7. Number of days with shoulder or arm pain from week 2 to week 7. [ Time Frame: 8 weeks ]
  8. Number of doses with analgesics from week 2 to week 7. [ Time Frame: 8 weeks ]
  9. Number of days with sick-leave from week 2 to week 7. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00184197

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Dept. of Neurology and Clinical Neurophysiology, Norwegian Headache Centre
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
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Principal Investigator: Lars Jacob Stovner, professor Dept. of Neurology and Clinical Neurophysiology
Publications of Results:
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Responsible Party: Norwegian University of Science and Technology Identifier: NCT00184197    
Other Study ID Numbers: 2004-000724-32
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Cervical muscles
Additional relevant MeSH terms:
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Post-Traumatic Headache
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs