Greater Occipital Nerve Injection Study

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 12-005836
    NCT ID: NCT01988363
    Sponsor Protocol Number: 12-005836

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Pingree, M.D.

Closed for enrollment

Contact information:

Kerry Crawley CCRP

Crawley.Kerry@mayo.edu

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CLS-20154111

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