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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.
 
ClinicalTrials.gov Identifier: NCT00184197
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date March 13, 2017
Actual Study Start Date  ICMJE May 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
Number of days with headache from week 2 after injection to week 7. [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Number of days with headache from week 2 after injection to week 7.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 1. No. of days until the patient has got > 50% of the pain level he or she had before the injection.
  • 2. No. of drop-outs due to long-lasting improvement after first injection
  • 3. No. of hours with headache from week 2 to week 7
  • 4. Average headache intensity from week 2 to week 7.
  • 5. Headache index (number of hours with headache times the number of pain intensity)
  • 6. Number of days with neck pain from week 2 to week 7.
  • 7. Number of days with shoulder or arm pain from week 2 to week 7.
  • 8. Number of doses with analgesics from week 2 to week 7.
  • 9. Number of days with sick-leave from week 2 to week 7.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache
Official Title  ICMJE Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache: A Prospective, Randomized, Double-blind, Cross-over Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervicogenic Headache
Intervention  ICMJE
  • Drug: Botulinum toxin
  • Drug: Placebos
Study Arms  ICMJE
  • Experimental: Botox
    Intervention: Drug: Botulinum toxin
  • Placebo Comparator: placebo
    Intervention: Drug: Placebos
Publications * 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. Epub 2011 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2017)
28
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
30
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00184197
Other Study ID Numbers  ICMJE 2004-000724-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars Jacob Stovner, professor Dept. of Neurology and Clinical Neurophysiology
PRS Account Norwegian University of Science and Technology
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP