- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04852393
Ultrasound-guided Cervical Medial Branch Blocks
November 27, 2023 updated by: Roderick Finlayson, Montreal General Hospital
A Prospective Evaluation of the Safety and Clinical Effects of Ultrasound-guided Cervical Medial Branch Blocks
In this study we will prospectively examine the safety and clinical effects of ultrasound-guided cervical medial branch blocks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Roderick J Finlayson, MD
- Phone Number: 250-860-9754
- Email: roderick.finlayson@mac.com
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1Y 0G1
- Bill Nelems Pain and Research Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients presenting to a tertiary outpatient pain clinic for diagnosis and treatment of chronic neck pain
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Block
Patients undergoing ultrasound-guided cervical medial branch blocks as part of their usual care
|
cervical medial branch block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate complications
Time Frame: 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)
|
Immediately after block
|
Delayed complications
Time Frame: 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).
|
14 days after block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported pain
Time Frame: Pre-block, then every 2 weeks for 3 months.
|
Lowest/highest/average pain score over last 7 days (NRS, 11-point scale)
|
Pre-block, then every 2 weeks for 3 months.
|
NDI
Time Frame: Pre-block, then every 2 weeks for 3 months.
|
Neck disability index
|
Pre-block, then every 2 weeks for 3 months.
|
PHQ-9
Time Frame: Pre-block then at 1,2 and 3 months post block.
|
Depression scale
|
Pre-block then at 1,2 and 3 months post block.
|
GAD-7
Time Frame: Pre-block then at 1,2 and 3 months post block.
|
Anxiety scale
|
Pre-block then at 1,2 and 3 months post block.
|
PCS
Time Frame: Pre-block then at 1,2 and 3 months post block.
|
Pain catastrophizing scale
|
Pre-block then at 1,2 and 3 months post block.
|
PGIC
Time Frame: Pre-block, then every 2 weeks for 3 months.
|
Patient global impression of change 7-point scale
|
Pre-block, then every 2 weeks for 3 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roderick J Finlayson, MD, University of British Columbia
- Principal Investigator: John-Paul B Etheridge, MD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2021
Primary Completion (Actual)
October 1, 2023
Study Completion (Actual)
October 1, 2023
Study Registration Dates
First Submitted
April 12, 2021
First Submitted That Met QC Criteria
April 15, 2021
First Posted (Actual)
April 21, 2021
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-21-105-H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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