Trial record 3 of 4 for:    Occipital Neuralgia

Greater Occipital Nerve Injection Study (GON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Matthew Pingree, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01988363
First received: November 7, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention Phase
Occipital Neuralgia
Cervicogenic Headache
Procedure: GON injection at C2 location
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound-guided Greater Occipital Nerve Injection at Novel Proximal Location: A Clinical Series

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Successful anesthesia of the GON [ Time Frame: 30 minutes post-injection ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes, 2 weeks, 1 month post-injection ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Description of ultrasound GON injection [ Time Frame: during injection ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 10
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988363

Contacts
Contact: Kerry S Crawley, BSW crawley.kerry@mayo.edu
Contact: Matthew J Pingree, MD pingree.matthew@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kerry S Crawley, BSW    507-255-8724    crawley.kerry@mayo.edu   
Principal Investigator: Matthew J Pingree, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Matthew Pingree, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Matthew Pingree, Assistant Professor of Physical Medicine and Rehabilitation, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01988363     History of Changes
Other Study ID Numbers: 12-005836
Study First Received: November 7, 2013
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
greater occipital nerve
occipital neuralgia
cervicogenic headache

Additional relevant MeSH terms:
Neuralgia
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014