NCT01988363

Greater Occipital Nerve Injection Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

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.

Conditions

• Occipital Neuralgia
• Cervicogenic Headache

Interventions

Type	Name	Description
PROCEDURE	GON injection at C2 location	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-11-20
• Last updated: 2015-03-11

Locations

1 site across 1 country: United States