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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
Patients must be referred to Pain Clinic for occipital nerve injection.
Patients are responsible for all clinical costs associated with the injection.
There is no remuneration offered for participation in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GON injection at C2 location | Other | A 25 gauge, 2 inch spinal needle will be inserted into the symptomatic side after locating the GON via US at the level of C2. Subjects will receive an injection of 4 ml of injectate consisting of 1 ml of 2% Lidocaine, 3 mg betamethasone and 2.5 ml of 0.25% Bupivicaine to the greater occipital nerve at the novel, proximal C2 location. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GON injection at C2 location | Procedure | GON will be identified at the novel, proximal C2 location on the symptomatic side via ultrasound guidance. Prior to injection, an independent examiner will perform a sensory exam of the involved dermatome. A 25 gauge spinal needle will be inserted into the symptomatic side after locating the GON via ultrasound at the C2 level. Subjects will be injected with treatment medication. Thirty minutes after injection, an independent examiner will test for anesthesia over the desired dermatome. VAS will be assessed pre-injection, 30 post-injection, 2 weeks post-injection and 1 month post-injection. The 2 week and 1 month assessments will be conducted by telephone. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful anesthesia of the GON | Demonstration of successful anesthesia post-injection in the dermatomal distribution of the greater occipital nerve following ultrasound guided injections at a novel, proximal C2 location in live, human subjects. | 30 minutes post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Scores | Obtain preliminary evidence of the efficacy of ultrasound guided greater occipital nerve injections at a novel, proximal C2 location in live, human subjects as measured by 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. | 30 minutes, 2 weeks, 1 month post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Description of ultrasound GON injection | To describe ultrasound guided greater occipital nerve injections in live, human subjects at a novel, proximal C2 location previously validated in cadaveric human models. This will include measurement of the cross-sectional area (mm^2), circumference (mm), depth from skin (cm) of the GON (cm), and presence or abscence of a vascular structure as measured with Doppler ultrasound. |
Inclusion Criteria:
Subjects must be referred to the Pain Clinic for an occipital nerve injection.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Pingree, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| during injection |
| D009422 | Nervous System Diseases |