Migraine Disorders
Conditions
Keywords
Pain, Nerve Blocks, Headache, Local Anaesthetics, Migraine
Brief summary
The investigators aimed to evaluate the efficacy of greater occipital nerve and supraorbital nerve blockade with local anesthetics for the preventive treatment of migraine without aura.
Detailed description
A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to GON and SON in the blockade patients. Placebo patients received 2 ml 0.9% saline in the same way. Patients were blinded to kind of injection.
Interventions
PROCEDURELidocaine injections
Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.
PROCEDURESaline injections
Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lack of benefits 1 year from preventive treatment or intolerance to their treatments. * 18 ≥ years old * Migraine without aura for more than 1 year, minimum of two or more migraine attacks per month.
Exclusion criteria
* Patients with any chronic illness, medication overuse headache, a history of cranial and cervical surgery * Allergies to local anesthetics * Hemorrhagic diathesis * Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Frequency of Headache | Patients were followed up from baseline to 2 months after first injection. | Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome. |
| Change of Severity of Headache | Patients were followed up for 2 months from baseline after first injection. | Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome |
Participant flow
Pre-assignment details
16 patients were excluded due to not meeting inclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| Blockade Group Grater occipital nerve and supraorbital nerve blockade injections with %2 lidocaine
Lidocaine injections: Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients. | 44 |
| Placebo Group Grater occipital nerve and supraorbital nerve injections with saline
Saline injections: Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve | 43 |
| Total | 87 |
Baseline characteristics
| Characteristic | Placebo Group | Total | Blockade Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 87 Participants | 44 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Turkey | 43 Participants | 87 Participants | 44 Participants |
| Sex: Female, Male Female | 37 Participants | 73 Participants | 36 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 28 |
| other Total, other adverse events | 37 / 43 | 19 / 28 |
| serious Total, serious adverse events | 0 / 43 | 0 / 28 |
Outcome results
Primary
Change of Frequency of Headache
Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.
Time frame: Patients were followed up from baseline to 2 months after first injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blockade Group | Change of Frequency of Headache | 5.3 score on a scale | Standard Deviation 7.4 |
| Placebo Group | Change of Frequency of Headache | 7.5 score on a scale | Standard Deviation 7.2 |
Primary
Change of Severity of Headache
Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome
Time frame: Patients were followed up for 2 months from baseline after first injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blockade Group | Change of Severity of Headache | 5.5 score on a scale | Standard Deviation 1.9 |
| Placebo Group | Change of Severity of Headache | 7.4 score on a scale | Standard Deviation 1.3 |