Greater Occipital Nerve Injection Study

NCT01988363 | Completed Phase 1

• 1 other identifier: 12-005836
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

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

Conditions

Occipital Neuralgia; Cervicogenic Headache

Keywords

greater occipital nerve; occipital neuralgia; cervicogenic headache

Outcome Measures

Primary Outcomes (1)

• Successful anesthesia of the GON

  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.

  30 minutes post-injection

Secondary Outcomes (1)

• Change in Pain Scores

  30 minutes, 2 weeks, 1 month post-injection

Other Outcomes (1)

• Description of ultrasound GON injection

  during injection

Study Arms (1)

GON injection at C2 location

OTHER

A 25 gauge, 2 inch spinal needle will be inserted into the symptomatic side after locating the GON via US at the level of C2. Subjects will receive an injection of 4 ml of injectate consisting of 1 ml of 2% Lidocaine, 3 mg betamethasone and 2.5 ml of 0.25% Bupivicaine to the greater occipital nerve at the novel, proximal C2 location.

Procedure: GON injection at C2 location

Interventions

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.

GON injection at C2 location

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew Pingree, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 20, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

US (1)