Greater Occipital Nerve Injection Study (GON)

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Occipital Neuralgia; Cervicogenic Headache

Treatments: Procedure: GON injection at C2 location

Study type: Interventional

Funder types: Other

Identifiers

NCT01988363

12-005836

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

GON injection at C2 location

Other group

Description:

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.

Treatment:

Procedure: GON injection at C2 location