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Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Botulinum toxin
Placebos
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Injection, Headache, Cervical muscles

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Neurology and Clinical Neurophysiology, Norwegian Headache Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botox

placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of days with headache from week 2 after injection to week 7.

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
March 10, 2017
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00184197
Brief Title
Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache
Official Title
Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache: A Prospective, Randomized, Double-blind, Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (Actual)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Injection, Headache, Cervical muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Intervention Type
Drug
Intervention Name(s)
Placebos
Primary Outcome Measure Information:
Title
Number of days with headache from week 2 after injection to week 7.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
No. of days until the patient has got > 50% of the pain level he or she had before the injection.
Time Frame
8 weeks
Title
No. of drop-outs due to long-lasting improvement after first injection
Time Frame
2 weeks
Title
No. of hours with headache from week 2 to week 7
Time Frame
8 weeks
Title
Average headache intensity from week 2 to week 7.
Time Frame
8 weeks
Title
Headache index (number of hours with headache times the number of pain intensity)
Time Frame
8 weeks
Title
Number of days with neck pain from week 2 to week 7.
Time Frame
8 weeks
Title
Number of days with shoulder or arm pain from week 2 to week 7.
Time Frame
8 weeks
Title
Number of doses with analgesics from week 2 to week 7.
Time Frame
8 weeks
Title
Number of days with sick-leave from week 2 to week 7.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Jacob Stovner, professor
Organizational Affiliation
Dept. of Neurology and Clinical Neurophysiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Neurology and Clinical Neurophysiology, Norwegian Headache Centre
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
21300635
Citation
Linde M, Hagen K, Salvesen O, 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.
Results Reference
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Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache

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