Clinical trial NCT01988363: Greater Occipital Nerve Injection Study
Official title: Ultrasound-guided Greater Occipital Nerve Injection at Novel Proximal Location: A Clinical Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Occipital Neuralgia
Cervicogenic Headache
Keywords: greater occipital nerve
occipital neuralgia
cervicogenic headache
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful anesthesia of the GON
timeFrame: 30 minutes post-injection
Secondary outcomes:
measure: Change in Pain Scores
timeFrame: 30 minutes, 2 weeks, 1 month post-injection
Other outcomes:
measure: Description of ultrasound GON injection
timeFrame: during injection
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Pingree, MD
role: PRINCIPAL_INVESTIGATOR
References: