Chronic MigrainePhase 2NCT02188394
Anesthetic Blockades and Migraine
A Phase 2 study testing Anesthetic blockades with bupivacaine and Isotonic saline injection in people with Chronic Migraine and Pain, run by César Fernández-de-las-Peñas at 1 site in Spain.
Trial summary
Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic blockades in chronic migraine and to analyze their… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronic Migraine, Pain
- What is being tested?
- Anesthetic blockades with bupivacaine and Isotonic saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Jan 2016
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic migraine
Who cannot join
- Other primary headaches
- Other secondary headaches
- Co-morbid medical diseases
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Clinico San Carlos-Universidad Complutense de Madrid
Madrid, Madrid
About this study
Official title: Effects of Anesthetic Blockades on Pain Modulation in Migraine
Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs) in different areas. We hypothesize that those patients receiving real GON anesthetic blockade will receive greater improvements in pain nociception. We will conduct a double-blind, randomized, parallel and placebo-controlled clinical trial where one group will be treated with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with placebo.
- Conditions
- Chronic Migraine, Pain
- Being tested
- Anesthetic blockades with bupivacaine, Isotonic saline injection
- Keywords
- migraine,, pressure pain,, anesthetic blocks, patients
- Medical subject headings
- Pain, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic blockades with bupivacaineDrug
Isotonic saline injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Anesthetic blockades with bupivacaine | Experimental | Patients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5% Receives: Drug: Anesthetic blockades with bupivacaine |
| Isotonic saline injection | Placebo comparator | Patients will receive a bilateral occipital injection with isotonic saline Receives: Drug: Isotonic saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the number of days with moderate/intense migraine
A headache diary will register the number of days with moderate/intense migraine. Moderate/intense migraine is considered a headache with an intensity level over 4 points on a numerical pain rate scale (NPRS, 0-10)
Measured: Baseline (1 week before) and 1 week after intervention
Secondary outcomes (3)
Changes in the number of days with mild/moderate migraine
A headache diary will register the number of days with mild/moderate migraine. Moderate/intense migraine is considered a headache with an intensity level under 4 points on a numerical pain rate scale (NPRS, 0-10)
Measured: Baseline (1 week before) and 1 week after intervention
Changes in the number of symptomatic medication drugs
The subjects will register in the headache diary the number of days per week in which they need symptomatic medical drugs for relief the headache attack
Measured: Baseline (1 week before) and 1 week after intervention
Changes in pressure pain thresholds
Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle
Measured: Baseline, 1 hour after and 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
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 Chronic MigraineStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- César Fernández-de-las-Peñas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- Maria Luz Cuadrado, MD; PhD, Principal investigator, Hospital Clinico San Carlos-Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188394
- Sponsor's protocol ID
- HCSC11/263
- Status last verified
- Jan 2016
- First submitted
- 10 Jul 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cuadrado ML, Aledo-Serrano A, Navarro P, Lopez-Ruiz P, Fernandez-de-Las-Penas C, Gonzalez-Suarez I, Orviz A, Fernandez-Perez C. Short-term effects of greater occipital nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical trial. Cephalalgia. 2017 Aug;37(9):864-872. doi: 10.1177/0333102416655159. Epub 2016 Jun 12.
PubMed 27296456
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anesthetic Blockades on Pain Modulation in Migraine
- ClinicalTrials.gov ID
- NCT02188394
- Acronym / sponsor ID
- HCSC11/263
- Conditions
- Chronic Migraine, Pain
- Keywords
- migraine,, pressure pain,, anesthetic blocks, patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- César Fernández-de-las-PeñasUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Jul 2014 (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.
Greater occipital nerve (GON) anesthetic blockades are widely used for the treatment of headaches, yet its efficacy in migraine has hardly been assessed with controlled studies. The aim of this study is to evaluate the short-term clinical efficacy of GON anaesthetic blockades in chronic migraine and to analyze their effect on pressure pain thresholds (PPTs) in different areas. We hypothesize that those patients receiving real GON anesthetic blockade will receive greater improvements in pain nociception. We will conduct a double-blind, randomized, parallel and placebo-controlled clinical trial where one group will be treated with bilateral GON blockade with bupivacaine 0,5% and the other group will be treated with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthetic blockades with bupivacaine | Experimental | Drug: Anesthetic blockades with bupivacainePatients will receive a bilateral greater occipital nerve blockade with bupivacaine 0,5% |
| Isotonic saline injection | Placebo comparator | Drug: Isotonic saline injectionPatients will receive a bilateral occipital injection with isotonic saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic migraine
Key exclusion criteria (3 listed)
- Other primary headaches
- Other secondary headaches
- Co-morbid medical diseases
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 |
|---|---|---|
| Anesthetic blockades with bupivacaine | Drug | Anesthetic blockades with bupivacaine |
| Isotonic saline injection | Drug | Isotonic saline injection |
Primary outcome
Changes in the number of days with moderate/intense migraine
Time frame: Baseline (1 week before) and 1 week after intervention
A headache diary will register the number of days with moderate/intense migraine. Moderate/intense migraine is considered a headache with an intensity level over 4 points on a numerical pain rate scale (NPRS, 0-10)
3 secondary outcomes
Changes in the number of days with mild/moderate migraine
Time frame: Baseline (1 week before) and 1 week after intervention
Changes in the number of symptomatic medication drugs
Time frame: Baseline (1 week before) and 1 week after intervention
Changes in pressure pain thresholds
Time frame: Baseline, 1 hour after and 1 week after intervention
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 5 Jan 2016.
- Derived from this study: PubMed 27296456Cuadrado ML, Aledo-Serrano A, Navarro P, Lopez-Ruiz P, Fernandez-de-Las-Penas C, Gonzalez-Suarez I, Orviz A, Fernandez-Perez C. Short-term effects of greater occipital nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical trial. Cephalalgia. 2017 Aug;37(9):864-872. doi: 10.1177/0333102416655159. Epub 2016 Jun 12.
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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.
Maria Luz Cuadrado, MD; PhD principal investigator
Hospital Clinico San Carlos-Universidad Complutense de Madrid
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 Anesthetic blockades with bupivacaine and Isotonic saline injection in people with Chronic Migraine and Pain, run by César Fernández-de-las-Peñas at 1 site in Spain.
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 1 inclusion and 3 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 5 Jan 2016. 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 Spain. 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?
Changes in the number of days with moderate/intense migraine (time frame: Baseline (1 week before) and 1 week after intervention). 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 NCT02188394, 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 5 Jan 2016.