Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03435185
• Collaborator: (none)
• Enrollment: 103
• Arms: 2
• Actual Duration (Months): 21

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders	Procedure: Lidocaine injections; Procedure: Saline injections	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Greater Occipital and Supraorbital Nerve Blockade For The Preventive Treatment of Migraine
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Blockade Group Lidocaine injections. Procedure. Grater occipital nerve and supraorbital nerve were blocked with %2 lidocaine. These injections were repeated weekly for three weeks. After treatment was completed, patients were followed up for 2 months at the polyclinic to assess the clinical response.	Procedure: 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.
Placebo Comparator: Placebo Group Saline injections. Procedure. Grater occipital nerve and supraorbital nerve were injected with saline.These injections were repeated weekly for three weeks. After treatment was completed, patients were followed up for 2 months at the polyclinic to assess the clinical response.	Procedure: Saline injections; Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Tang Y, Kang J, Zhang Y, Zhang X. Influence of greater occipital nerve block on pain severity in migraine patients: A systematic review and meta-analysis. Am J Emerg Med. 2017 Nov;35(11):1750-1754. doi: 10.1016/j.ajem.2017.08.027. Epub 2017 Aug 14. Review.

• Responsible Party: Cem Bölük, Medical Doctor, Dr. Lutfi Kirdar Kartal Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03435185
• Other Study ID Numbers: 2014/514/85/5
• First Posted: Feb 15, 2018
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cem Bölük, Medical Doctor, Dr. Lutfi Kirdar Kartal Training and Research Hospital: Pain; Nerve Blocks; Headache; Local Anaesthetics; Migraine
• Additional relevant MeSH terms: Migraine Disorders; Lidocaine

Study Results

Participant Flow

Pre-assignment Detail	16 patients were excluded due to not meeting inclusion criteria

Arm/Group Title	Blockade Group	Placebo Group
Arm/Group Description	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.	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
Period Title: Overall Study
STARTED	44	43
COMPLETED	43	28
NOT COMPLETED	1	15

Baseline Characteristics

Arm/Group Title	Blockade Group	Placebo Group	Total
Arm/Group Description	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.	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	Total of all reporting groups
Overall Participants	44	43	87
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	44 100%	43 100%	87 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	36 81.8%	37 86%	73 83.9%
Male	8 18.2%	6 14%	14 16.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Turkey	44 100%	43 100%	87 100%

Outcome Measures

1. Primary Outcome

Title	Change of Frequency of Headache
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blockade Group	Placebo Group
Arm/Group Description	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.	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
Measure Participants	43	28
Mean (Standard Deviation) [score on a scale]	5.3 (7.4)	7.5 (7.2)

2. Primary Outcome

Title	Change of Severity of Headache
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blockade Group	Placebo Group
Arm/Group Description	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.	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
Measure Participants	43	28
Mean (Standard Deviation) [score on a scale]	5.5 (1.9)	7.4 (1.3)

Adverse Events

Time Frame	10 months
Adverse Event Reporting Description	Clinically observed adverse events
Arm/Group Title	Blockade Group		Placebo Group
Arm/Group Description	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.		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
All Cause Mortality
	Blockade Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/28 (0%)
Serious Adverse Events
	Blockade Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Blockade Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/43 (86%)		19/28 (67.9%)
Skin and subcutaneous tissue disorders
Minor Bleedings	37/43 (86%)		19/28 (67.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.