Ultrasound-guided Cervical Medial Branch Blocks

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852393
• Other study ID #: 2020-21-105-H
• Status: Completed
• Start date: May 5, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: Montreal General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spondylosis
• Neck Pain
• Spondylosis

Intervention

Procedure:
• Block
cervical medial branch block

Locations

Country	Name	City	State
Canada	Bill Nelems Pain and Research Centre	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Montreal General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	NDI	Neck disability index	Pre-block, then every 2 weeks for 3 months.
Secondary	PHQ-9	Depression scale	Pre-block then at 1,2 and 3 months post block.
Secondary	GAD-7	Anxiety scale	Pre-block then at 1,2 and 3 months post block.
Secondary	PCS	Pain catastrophizing scale	Pre-block then at 1,2 and 3 months post block.
Secondary	PGIC	Patient global impression of change 7-point scale	Pre-block, then every 2 weeks for 3 months.