NCT04852393

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.4 years

First QC Date

April 12, 2021

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Patient reported pain

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

  • NDI

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

  • PHQ-9

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

  • GAD-7

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

  • PCS

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

  • +1 more secondary outcomes

Study Arms (1)

Block

Patients undergoing ultrasound-guided cervical medial branch blocks as part of their usual care

Procedure: Block

Interventions

BlockPROCEDURE

cervical medial branch block

Block

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to a tertiary outpatient pain clinic for diagnosis and treatment of chronic neck pain

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bill Nelems Pain and Research Centre

Kelowna, British Columbia, V1Y 0G1, Canada

Location

Related Publications (2)

  • Finlayson RJ, Etheridge JB, Godard R, Kaseweter K, Etheridge JP, Curatolo M. Do cervical medial branch blocks have a therapeutic role? a prospective cohort study. Reg Anesth Pain Med. 2025 May 28:rapm-2025-106457. doi: 10.1136/rapm-2025-106457. Online ahead of print.

  • Etheridge JB, Finlayson RJ, Venter J, De Villiers F, Etheridge JP, Wakefield R, Watanitanon A. Prospective evaluation of the safety of ultrasound-guided cervical medial branch blocks using the in-plane technique. Reg Anesth Pain Med. 2025 Mar 5;50(3):237-242. doi: 10.1136/rapm-2024-105296.

MeSH Terms

Conditions

Neck PainSpondylosis

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Roderick J Finlayson, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • John-Paul B Etheridge, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 21, 2021

Study Start

May 5, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations