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

Primary Purpose

Occipital Neuralgia, Cervicogenic Headache, Migraine Without Aura

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Guided Greater Occipital Nerve Block at C2
Landmark-Based Greater Occipital Nerve Block
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Occipital Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound Guided GON Block at C2

Landmark based GON Block

Arm Description

Ultrasound Guided Greater Occipital Nerve Block at C2

Landmark-Based Greater Occipital Nerve Block

Outcomes

Primary Outcome Measures

Change in Numeric Rating Scale (NRS) Pain Score
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

Change in number of patients with medication overuse
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.
Change in number of headache days per month
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.
Change in Headache Impact Test (HIT-6) Score
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).

Full Information

First Posted
March 21, 2018
Last Updated
June 14, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03478735
Brief Title
Ultrasound Greater Occipital Nerve Block at C2 Level Compared to Landmark-based Greater Occipital Nerve Block
Official Title
Ultrasound-guided Greater Occipital Nerve Block at the C2 Level Compared to Landmark-based Greater Occipital Nerve Block: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
June 14, 2021 (Actual)
Study Completion Date
June 14, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occipital Neuralgia, Cervicogenic Headache, Migraine Without Aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound Guided GON Block at C2
Arm Type
Experimental
Arm Description
Ultrasound Guided Greater Occipital Nerve Block at C2
Arm Title
Landmark based GON Block
Arm Type
Active Comparator
Arm Description
Landmark-Based Greater Occipital Nerve Block
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Greater Occipital Nerve Block at C2
Intervention Description
Ultrasound guided injection
Intervention Type
Procedure
Intervention Name(s)
Landmark-Based Greater Occipital Nerve Block
Intervention Description
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 Measure Information:
Title
Change in Numeric Rating Scale (NRS) Pain Score
Description
Pain intensity will be assessed using a NRS marked from 0-10 with fixed intervals, with 0=no pain, and 10=worst pain.
Time Frame
baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change in number of patients with medication overuse
Description
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.
Time Frame
baseline, 4 weeks
Title
Change in number of headache days per month
Description
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.
Time Frame
baseline, 4 weeks
Title
Change in Headache Impact Test (HIT-6) Score
Description
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).
Time Frame
baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Age 18 years and older (no upper age limit defined) Imaging of cervical spine within last year (either x-ray, MRI or CT) Exclusion Criteria: History of cervical spine surgery, trauma, or surgical procedure involving head or neck during the last year Use of new preventative medications 1 month prior or during study enrollment Evidence of impaired sensation in the GON dermatome region (posterior scalp to the vertex of the cranium) from neurological, dermatological, or other disease process Evidence of cranial defect or other anatomical abnormality near the target injection site History of bleeding diathesis, coagulopathy, or current use of anticoagulant medications Pregnancy History of adverse reaction or allergy to local anesthetic agents or corticosteroids Occipital nerve block within the past three months. Unavailability for appropriate follow-up throughout the whole duration of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J 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

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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