Chronic Migraine, Pain
Conditions
Keywords
migraine,, pressure pain,, anesthetic blocks, patients
Brief 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 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.
Interventions
DRUGAnesthetic blockades with bupivacaine
Sponsors
César Fernández-de-las-Peñas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic migraine
Exclusion criteria
* Other primary headaches * Other secondary headaches * Co-morbid medical diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the number of days with moderate/intense migraine | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the number of days with mild/moderate migraine | Baseline (1 week before) and 1 week after intervention | 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) |
| Changes in the number of symptomatic medication drugs | Baseline (1 week before) and 1 week after intervention | 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 |
| Changes in pressure pain thresholds | Baseline, 1 hour after and 1 week after intervention | Pressure pain thresholds will be assessed over the supraorbital, infraorbital and mental nerves, and over the second metacarpal and tibialis anterior muscle |
Countries
Spain
Outcome results
None listed