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Ultrasound Greater Occipital Nerve Block at C2 Level Compared to Landmark-based Greater Occipital Nerve Block

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ClinicalTrials.gov Identifier: NCT03478735
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Pingree, Mayo Clinic

Brief Summary:
This study will compare the analgesic benefit of a traditional landmark-guided GON block with the ultrasound-guided approach over a four week period in patients with occipital neuralgia or cervicogenic headache.

Condition or disease Intervention/treatment Phase
Occipital Neuralgia Cervicogenic Headache Migraine Without Aura Procedure: Ultrasound Guided Greater Occipital Nerve Block at C2 Procedure: Landmark-Based Greater Occipital Nerve Block Not Applicable

Detailed Description:

Hypothesis: A novel ultrasound-guided greater occipital nerve (GON) block at the level of C2 will result in significantly lower pain scores after 4 weeks when compared with a traditional landmark-guided approach at the superior nuchal line.

The greater occipital nerve (GON) has been implicated in several conditions that prompt referral to pain medicine specialists, including occipital neuralgia and cervicogenic headache. According to the International Headache Society, a local anesthetic block of the GON can aid in the diagnosis and treatment of occipital neuralgia. Many practitioners perform GON injections using a conventional approach, relying solely on superficial bone-based anatomic landmarks to infiltrate local anesthetic and corticosteroid around the nerve at the level of the superior nuchal line. The ambiguity of these injections poses a risk of anesthetizing adjacent structures or injecting into vessels, such as the occipital artery.

In an attempt to mitigate these risks and improve the efficacy of GON injections, ultrasound has been increasingly utilized. Multiple studies have demonstrated successful ultrasound-guided GON blockade at the superior nuchal line and improvement in pain scores compared to non-guided injections. The investigators' preliminary data confirms the feasibility, efficacy, and safety of an ultrasound-guided GON block technique at the level of C2, but it is not yet known whether this technique provides greater pain relief and functional outcomes compared to traditional injections.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Greater Occipital Nerve Block at the C2 Level Compared to Landmark-based Greater Occipital Nerve Block: A Randomized Controlled Trial
Actual Study Start Date : July 17, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound Guided GON Block at C2
Ultrasound Guided Greater Occipital Nerve Block at C2
Procedure: Ultrasound Guided Greater Occipital Nerve Block at C2
Ultrasound guided injection

Active Comparator: Landmark based GON Block
Landmark-Based Greater Occipital Nerve Block
Procedure: Landmark-Based Greater Occipital Nerve Block
Traditional landmark-guided technique at the superior nuchal line. This approach relies solely on superficial bone-based anatomic landmarks to infiltrate local anesthetic and corticosteroid around the nerve at the level of the superior nuchal line.




Primary Outcome Measures :
  1. Change in Numeric Rating Scale (NRS) Pain Score [ Time Frame: baseline, 4 weeks ]
    Pain intensity will be assessed using a NRS marked from 0-10 with fixed intervals, with 0=no pain, and 10=worst pain.


Secondary Outcome Measures :
  1. Change in number of patients with medication overuse [ Time Frame: baseline, 4 weeks ]
    The subjects will be provided a headache journal to record the number of days they have been using each of their analgesic medications. Medication overuse will be defined as the use of acetaminophen or non-steroidal anti-inflammatory drugs > 14 days a month, triptan, ergotamine, or combination-analgesic medications (e.g.,caffeine containing) medications >9 days a month, and opioid or butalbital containing medications >5 days a month.

  2. Change in number of headache days per month [ Time Frame: baseline, 4 weeks ]
    The number of headache days per month will be obtained at baseline prior to injection in the pain clinic and at 4 weeks post-injection via telephone.

  3. Change in Headache Impact Test (HIT-6) Score [ Time Frame: baseline, 4 weeks ]
    The HIT-6 show the effect that headaches have on normal daily life and the subject's ability to function. It consists of 6 questions; possible responses being never (6 points each), rarely (8 points each), sometimes (10 points each), very often (11 points each), and always (13 points each). The total score ranges from 36 (little to no impact) to 78 (very severe impact).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Unilateral or bilateral headache symptoms attributed to occipital neuralgia or cervicogenic headache as defined by the International Headache Society's International Classification of Headache Disorders (3rd edition beta version)
  2. Age 18 years and older (no upper age limit defined)
  3. Imaging of cervical spine within last year (either x-ray, MRI or CT)

Exclusion Criteria:

  1. History of cervical spine surgery, trauma, or surgical procedure involving head or neck during the last year
  2. Use of new preventative medications 1 month prior or during study enrollment
  3. Evidence of impaired sensation in the GON dermatome region (posterior scalp to the vertex of the cranium) from neurological, dermatological, or other disease process
  4. Evidence of cranial defect or other anatomical abnormality near the target injection site
  5. History of bleeding diathesis, coagulopathy, or current use of anticoagulant medications
  6. Pregnancy
  7. History of adverse reaction or allergy to local anesthetic agents or corticosteroids
  8. Occipital nerve block within the past three months.
  9. Unavailability for appropriate follow-up throughout the whole duration of study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478735


Contacts
Contact: Suanne M Weist, BSN 507-255-6804 weist.suanne@mayo.edu
Contact: Linda S Weise, RRT 507-293-2535 weise.linda@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Matthew J Pingree, MD Mayo Clinic

Responsible Party: Matthew Pingree, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03478735     History of Changes
Other Study ID Numbers: 17-002724
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine without Aura
Migraine Disorders
Headache
Neuralgia
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders, Secondary