Ultrasound-guided Greater Occipital Nerve Injection at Novel Proximal Location: A Clinical Series

Mayo Clinic1 site in 1 country15 target enrollmentJune 2013

ConditionsOccipital Neuralgia Cervicogenic Headache

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Occipital Neuralgia
Sponsor: Mayo Clinic
Enrollment: 15
Locations: 1
Primary Endpoint: Successful anesthesia of the GON
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to answer the question of whether injection of the greater occipital nerve at its proximal origin, near the C2 vertebrae, using ultrasound guidance is effective in improving pain in human subjects.

HYPOTHESES

Ultrasound (US) guided greater occipital nerve (GON) injections are effective at a novel, proximal C2 location in live, human subjects, measured by improvement in visual analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection, and 1-month post-injection .
Ultrasound (US) guided injection of the greater occipital nerve (GON) at a novel, C2 location is effective at improvement of both occipital neuralgia and cervicogenic headache demonstrated by improvement in visual analog scale (VAS) pain scores pre-injection compared to VAS scores 30 minutes post-injection, 2-weeks post-injection, and 1-month post-injection. We further hypothesize that the mean improvement in VAS scores at 1-month post injection will be greater than 2 units.
Ultrasound (US) guided injection of the greater occipital nerve (GON) at novel, proximal C2 location in live, human subjects appears safe.

Detailed Description

Patients must be referred to Pain Clinic for occipital nerve injection. Patients are responsible for all clinical costs associated with the injection. There is no remuneration offered for participation in this study.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

February 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Matthew Pingree

Assistant Professor of Physical Medicine and Rehabilitation

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Subjects must be referred to the Pain Clinic for an occipital nerve injection.
•Must have Occipital Neuralgia and/or Cervicogenic Headache

Exclusion Criteria

•Bilateral GON symptoms and/or cervicogenic headache symptoms
•History of cervical spine surgery/procedure or trauma in past 6 months that may have caused or contributed to the occipital pain or cervicogenic headache, excluding Occipital Nerve Blocks (ONB).
•Evidence of impaired sensation in the GON dermatome region
•Evidence of cranial defect/abnormality near target injection site
•Untreated cutaneous infection, systemic illness, or immunocompromised state
•History of bleeding tendency or use of anticoagulants
•History of adverse reaction to anesthetic agents or corticosteroids
•Occipital nerve block in past 3 months

Outcomes

Primary Outcomes

Successful anesthesia of the GON

Time Frame: 30 minutes post-injection

Demonstration of successful anesthesia post-injection in the dermatomal distribution of the greater occipital nerve following ultrasound guided injections at a novel, proximal C2 location in live, human subjects.