Cervicogenic HeadachePhase 2NCT00184197
Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache
A Phase 2 study testing Botulinum toxin in people with Cervicogenic Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Botulinum toxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- May 2005to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Headache strictly unilateral without side-shift
- Traits indicating involvement of neck structures, fulfilling at least 2 of the following:
- Reduced neck range of motion II. Typical headache can be elicited by palpation or pressure on muscles of the occiput or in the neck.
- Typical headache can be precipitated by certain neck movements or by adopting a certain position of the head.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of Neurology and Clinical Neurophysiology, Norwegian Headache Centre
Trondheim, 7006
About this study
Official title: Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache: A Prospective, Randomized, Double-blind, Cross-over Study
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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Botulinum toxin, Placebos
- Keywords
- Injection, Headache, Cervical muscles
- Medical subject headings
- Post-Traumatic Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Botox | Experimental | Not described Receives: Drug: Botulinum toxin |
| placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with headache from week 2 after injection to week 7.
Measured: 8 weeks
Secondary outcomes (9)
No. of days until the patient has got > 50% of the pain level he or she had before the injection.
Measured: 8 weeks
No. of drop-outs due to long-lasting improvement after first injection
Measured: 2 weeks
No. of hours with headache from week 2 to week 7
Measured: 8 weeks
Average headache intensity from week 2 to week 7.
Measured: 8 weeks
Headache index (number of hours with headache times the number of pain intensity)
Measured: 8 weeks
Number of days with neck pain from week 2 to week 7.
Measured: 8 weeks
Number of days with shoulder or arm pain from week 2 to week 7.
Measured: 8 weeks
Number of doses with analgesics from week 2 to week 7.
Measured: 8 weeks
Number of days with sick-leave from week 2 to week 7.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Jacob Stovner, professor, Principal investigator, Dept. of Neurology and Clinical Neurophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184197
- Sponsor's protocol ID
- 2004-000724-32
- Other IDs
- 2004
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21300635
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Injection in Neck Muscles in Cervicogenic Headache: A Prospective, Randomized, Double-blind, Cross-over Study
- ClinicalTrials.gov ID
- NCT00184197
- Acronym / sponsor ID
- 2004-000724-32
- Conditions
- Cervicogenic Headache
- Keywords
- Injection, Headache, Cervical muscles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- May 2005 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox | Experimental | Drug: Botulinum toxin |
| placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Headache strictly unilateral without side-shift
- Traits indicating involvement of neck structures, fulfilling at least 2 of the following:
- Reduced neck range of motion II. Typical headache can be elicited by palpation or pressure on muscles of the occiput or in the neck.
- Typical headache can be precipitated by certain neck movements or by adopting a certain position of the head.
- There is a radiation of pain to the ipsilateral shoulder or arm.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin | Drug | Botox |
| Placebos | Drug | placebo |
Primary outcome
Number of days with headache from week 2 after injection to week 7.
Time frame: 8 weeks
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Results publication: PubMed 21300635Linde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Jacob Stovner, professor principal investigator
Dept. of Neurology and Clinical Neurophysiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin in people with Cervicogenic Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with headache from week 2 after injection to week 7. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.