Occipital NeuralgiaNCT03478735
Ultrasound Greater Occipital Nerve Block at C2 Level Compared to Landmark-based Greater Occipital Nerve Block
A study testing Ultrasound Guided Greater Occipital Nerve Block at C2 and Landmark-Based Greater Occipital Nerve Block in people with Occipital Neuralgia and Cervicogenic Headache, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occipital Neuralgia, Cervicogenic Headache, Migraine Without Aura
- What is being tested?
- Ultrasound Guided Greater Occipital Nerve Block at C2 and Landmark-Based Greater Occipital Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 14 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Ultrasound-guided Greater Occipital Nerve Block at the C2 Level Compared to Landmark-based Greater Occipital Nerve Block: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Ultrasound Guided Greater Occipital Nerve Block at C2, Landmark-Based Greater Occipital Nerve Block
- Medical subject headings
- Post-Traumatic Headache, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Greater Occipital Nerve Block at C2Procedure or surgery
Ultrasound guided injection
Landmark-Based Greater Occipital Nerve BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided GON Block at C2 | Experimental | Ultrasound Guided Greater Occipital Nerve Block at C2 Receives: Procedure: Ultrasound Guided Greater Occipital Nerve Block at C2 |
| Landmark based GON Block | Active comparator | Landmark-Based Greater Occipital Nerve Block Receives: Procedure: Landmark-Based Greater Occipital Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4 weeks
Secondary outcomes (3)
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.
Measured: baseline, 4 weeks
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.
Measured: baseline, 4 weeks
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).
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start17 Jul 2017
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occipital NeuralgiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Pingree, Mayo Clinic
- Investigators
- Matthew J Pingree, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478735
- Sponsor's protocol ID
- 17-002724
- Status last verified
- Jun 2021
- First submitted
- 21 Mar 2018
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Greater Occipital Nerve Block at the C2 Level Compared to Landmark-based Greater Occipital Nerve Block: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03478735
- Acronym / sponsor ID
- 17-002724
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided GON Block at C2 | Experimental | Procedure: Ultrasound Guided Greater Occipital Nerve Block at C2Ultrasound Guided Greater Occipital Nerve Block at C2 |
| Landmark based GON Block | Active comparator | Procedure: Landmark-Based Greater Occipital Nerve BlockLandmark-Based Greater Occipital Nerve Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Guided Greater Occipital Nerve Block at C2Ultrasound guided injection | Procedure or surgery | Ultrasound Guided GON Block at C2 |
| Landmark-Based Greater Occipital Nerve BlockTraditional 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. | Procedure or surgery | Landmark based GON Block |
Primary outcome
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.
3 secondary outcomes
Change in number of patients with medication overuse
Time frame: baseline, 4 weeks
Change in number of headache days per month
Time frame: baseline, 4 weeks
Change in Headache Impact Test (HIT-6) Score
Time frame: baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Pingree, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Greater Occipital Nerve Block at C2 and Landmark-Based Greater Occipital Nerve Block in people with Occipital Neuralgia and Cervicogenic Headache, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Rating Scale (NRS) Pain Score (time frame: baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.