Ultrasound-guided Cervical Medial Branch Blocks

Study Overview
=================
Brief Summary
-----------------
In this study we will prospectively examine the safety and clinical effects of ultrasound-guided cervical medial branch blocks.

Detailed Description
-----------------
While several clinical trials have found that ultrasound guidance provides similar accuracy to fluoroscopy and reduces performance times for cervical medial branch blocks, larger studies documenting safety-related outcomes are lacking. In addition, although cervical medial branch blocks are an accepted tool to diagnose neck pain originating from the cervical facets, there are reports of long-lasting analgesic effects in a subset of patients, suggesting that these blocks may have long-term benefits. We therefore propose to prospectively examine the incidence of adverse events, as well as the clinical long-term effects of ultrasound-guided cervical medial branch blocks, in a cohort of pain clinic patients undergoing these procedures as part of their usual care.

Official Title
-----------------
A Prospective Evaluation of the Safety and Clinical Effects of Ultrasound-guided Cervical Medial Branch Blocks

Conditions
-----------------
Neck Pain, Cervical Spondylosis

Intervention / Treatment
-----------------
* Procedure: Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consenting patients over 18 years of age undergoing cervical medial branch blocks as part of their usual care and who have a pain intensity of at least 5/10 (at rest or on movement) and a pain duration of at least 4 months. Exclusion Criteria: Inability to communicate or complete follow up questionnaires Known bleeding disorder or coagulopathy Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents) Inability to visualize targeted structures on ultrasound Presence of acute radiculopathy of new onset neurological symptoms in the upper extremities Patients with bilateral neck pain if only one side is treated

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Block<br>Patients undergoing ultrasound-guided cervical medial branch blocks as part of their usual care | Procedure: Block<br>* cervical medial branch block<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate complications | Proportion of patients with immediate block-related complications including any of the following: vasovagal, local anesthetic toxicity (dizziness, tinnitus, altered LOC, seizure) and trauma to non-targeted neural structures (paresthesia or other neuro symptoms) | Immediately after block | 
| Delayed complications | Proportion of patients with delayed block-related complications including any of the following: redness/irritation/swelling at injection site, hematoma, infection, skin bruising, soreness at injection site or increased pain, any neurological symptoms (new onset radicular pain, numbness/weakness or paresthesia in upper extremities). | 14 days after block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported pain | Lowest/highest/average pain score over last 7 days (NRS, 11-point scale) | Pre-block, then every 2 weeks for 3 months. | 
| NDI | Neck disability index | Pre-block, then every 2 weeks for 3 months. | 
| PHQ-9 | Depression scale | Pre-block then at 1,2 and 3 months post block. | 
| GAD-7 | Anxiety scale | Pre-block then at 1,2 and 3 months post block. | 
| PCS | Pain catastrophizing scale | Pre-block then at 1,2 and 3 months post block. | 
| PGIC | Patient global impression of change 7-point scale | Pre-block, then every 2 weeks for 3 months. |