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
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- 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).
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
|Contact: Suanne M Weist, BSNfirstname.lastname@example.org|
|Contact: Linda S Weise, RRTemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Matthew J Pingree, MD||Mayo Clinic|