Skip to main content
OpenTrials
Completed

NCT Number: NCT01988363

Greater Occipital Nerve Injection Study

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

1. 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 . 2. 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. 3. Ultrasound (US) guided injection of the greater occipital nerve (GON) at novel, proximal C2 location in live, human subjects appears safe.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Occipital Neuralgia Brain Diseases Central Nervous System Diseases Cervicogenic Headache Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Traumatic Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GON injection at C2 location

Procedure

GON will be identified at the novel, proximal C2 location on the symptomatic side via ultrasound guidance. Prior to injection, an independent examiner will perform a sensory exam of the involved dermatome. A 25 gauge spinal needle will be inserted into the symptomatic side after locating the GON via ultrasound at the C2 level. Subjects will be injected with treatment medication. Thirty minutes after injection, an independent examiner will test for anesthesia over the desired dermatome. VAS will be assessed pre-injection, 30 post-injection, 2 weeks post-injection and 1 month post-injection. The 2 week and 1 month assessments will be conducted by telephone.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Pain Scores

    Time frame: 30 minutes, 2 weeks, 1 month post-injection

    Obtain preliminary evidence of the efficacy of ultrasound guided greater occipital nerve injections at a novel, proximal C2 location in live, human subjects as measured by 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.

Other outcomes

  1. Description of ultrasound GON injection

    Time frame: during injection

    To describe ultrasound guided greater occipital nerve injections in live, human subjects at a novel, proximal C2 location previously validated in cadaveric human models. This will include measurement of the cross-sectional area (mm^2), circumference (mm), depth from skin (cm) of the GON (cm), and presence or abscence of a vascular structure as measured with Doppler ultrasound.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: GON

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2013
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.