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Greater Occipital Nerve Injection Study (GON)

Primary Purpose

Occipital Neuralgia, Cervicogenic Headache

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GON injection at C2 location
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Occipital Neuralgia focused on measuring greater occipital nerve, occipital neuralgia, cervicogenic headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

GON injection at C2 location

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 7, 2013
Last Updated
March 9, 2015
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01988363
Brief Title
Greater Occipital Nerve Injection Study
Acronym
GON
Official Title
Ultrasound-guided Greater Occipital Nerve Injection at Novel Proximal Location: A Clinical Series
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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 . 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occipital Neuralgia, Cervicogenic Headache
Keywords
greater occipital nerve, occipital neuralgia, cervicogenic headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GON injection at C2 location
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
GON injection at C2 location
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful anesthesia of the GON
Description
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.
Time Frame
30 minutes post-injection
Secondary Outcome Measure Information:
Title
Change in Pain Scores
Description
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.
Time Frame
30 minutes, 2 weeks, 1 month post-injection
Other Pre-specified Outcome Measures:
Title
Description of ultrasound GON injection
Description
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.
Time Frame
during injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Pingree, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Greater Occipital Nerve Injection Study

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