Greater Occipital Nerve Injection Study

NCT ID: NCT01988363

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-02-28

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.

Conditions

Occipital Neuralgia; Cervicogenic Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GON injection at C2 location

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.

Group Type: OTHER

GON injection at C2 location

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Matthew Pingree

Assistant Professor of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Pingree, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

12-005836

Identifier Type: -

Identifier Source: org_study_id