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Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184197
First received: September 12, 2005
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Cervicogenic Headache
Drug: Botulinum toxin
Drug: Placebos
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Actual Study Start Date: May 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox Drug: Botulinum toxin
Placebo Comparator: placebo Drug: Placebos

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184197

Locations
Norway
Dept. of Neurology and Clinical Neurophysiology, Norwegian Headache Centre
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Lars Jacob Stovner, professor Dept. of Neurology and Clinical Neurophysiology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184197     History of Changes
Other Study ID Numbers: 2004-000724-32
Study First Received: September 12, 2005
Last Updated: March 10, 2017

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:
Injection
Headache
Cervical muscles

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 23, 2017