Ultrasound-guided Cervical Medial Branch Blocks

Completed

• Conditions: Cervical Spondylosis; Neck Pain
• Interventions: Procedure: Block

• Registration Number: NCT04852393
• Lead Sponsor: Montreal General Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-15
• Study First Posted: 2021-04-21
• Study Start: 2021-05-05
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Block	Block	Patients undergoing ultrasound-guided cervical medial branch blocks as part of their usual care

Primary Outcome Measures

Name	Time	Method
Delayed complications	14 days after block	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).
Immediate complications	Immediately after block	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bill Nelems Pain and Research Centre; 🇨🇦 Kelowna, British Columbia, Canada