Ultrasound-guided Cervical Medial Branch Blocks

Montreal General Hospital500 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Neck Pain Cervical Spondylosis

Interventions

BlockPROCEDURE

cervical medial branch block

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Bill Nelems Pain and Research Centre

Kelowna, British Columbia, Canada

Outcomes

Primary Outcomes

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)

Time frame: 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).

Time frame: 14 days after block

Secondary Outcomes

Patient reported pain

Lowest/highest/average pain score over last 7 days (NRS, 11-point scale)

Time frame: Pre-block, then every 2 weeks for 3 months.

NDI

Neck disability index

Time frame: Pre-block, then every 2 weeks for 3 months.

PHQ-9

Depression scale

Time frame: Pre-block then at 1,2 and 3 months post block.

GAD-7

Anxiety scale

Time frame: Pre-block then at 1,2 and 3 months post block.

PCS

Pain catastrophizing scale

Time frame: Pre-block then at 1,2 and 3 months post block.

PGIC

Data from ClinicalTrials.gov

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