Ultrasound Greater Occipital Nerve Block at C2 Level Compared to Landmark-based Greater Occipital Nerve Block

NCT03478735 | Completed

• 1 other identifier: 17-002724
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the analgesic benefit of a traditional landmark-guided GON block with the ultrasound-guided approach over a four week period in patients with occipital neuralgia or cervicogenic headache.

Conditions

Occipital Neuralgia; Cervicogenic Headache; Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Scale (NRS) Pain Score

  Pain intensity will be assessed using a NRS marked from 0-10 with fixed intervals, with 0=no pain, and 10=worst pain.

  baseline, 4 weeks

Secondary Outcomes (3)

• Change in number of patients with medication overuse

  baseline, 4 weeks

• Change in number of headache days per month

  baseline, 4 weeks

• Change in Headache Impact Test (HIT-6) Score

  baseline, 4 weeks

Study Arms (2)

Ultrasound Guided GON Block at C2

EXPERIMENTAL

Ultrasound Guided Greater Occipital Nerve Block at C2

Procedure: Ultrasound Guided Greater Occipital Nerve Block at C2

Landmark based GON Block

ACTIVE COMPARATOR

Landmark-Based Greater Occipital Nerve Block

Procedure: Landmark-Based Greater Occipital Nerve Block

Interventions

Ultrasound Guided Greater Occipital Nerve Block at C2 PROCEDURE

Ultrasound guided injection

Ultrasound Guided GON Block at C2

Landmark-Based Greater Occipital Nerve Block PROCEDURE

Traditional landmark-guided technique at the superior nuchal line. This approach relies solely on superficial bone-based anatomic landmarks to infiltrate local anesthetic and corticosteroid around the nerve at the level of the superior nuchal line.

Landmark based GON Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral or bilateral headache symptoms attributed to occipital neuralgia or cervicogenic headache as defined by the International Headache Society's International Classification of Headache Disorders (3rd edition beta version)
• Age 18 years and older (no upper age limit defined)
• Imaging of cervical spine within last year (either x-ray, MRI or CT)

You may not qualify if:

• History of cervical spine surgery, trauma, or surgical procedure involving head or neck during the last year
• Use of new preventative medications 1 month prior or during study enrollment
• Evidence of impaired sensation in the GON dermatome region (posterior scalp to the vertex of the cranium) from neurological, dermatological, or other disease process
• Evidence of cranial defect or other anatomical abnormality near the target injection site
• History of bleeding diathesis, coagulopathy, or current use of anticoagulant medications
• Pregnancy
• History of adverse reaction or allergy to local anesthetic agents or corticosteroids
• Occipital nerve block within the past three months.
• Unavailability for appropriate follow-up throughout the whole duration of study

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Post-Traumatic Headache; Migraine without Aura

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Migraine Disorders; Headache Disorders, Primary

Study Officials

• Matthew J Pingree, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: July 17, 2017
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)