Greater Occipital Nerve Injection Study

Cervicogenic Headache Clinical Trial

— GON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988363
• Other study ID #: 12-005836
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2013
• Last updated: March 9, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervicogenic Headache
• Neuralgia
• Occipital Neuralgia
• Post-Traumatic Headache

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Description of ultrasound GON 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.	during injection	Yes
Primary	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	No
Secondary	Change in Pain Scores	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.	30 minutes, 2 weeks, 1 month post-injection	No