Neck PainNCT04852393
Ultrasound-guided Cervical Medial Branch Blocks
An observational study of Neck Pain and Cervical Spondylosis, run by Montreal General Hospital at 1 site in Canada.
Trial summary
In this study we will prospectively examine the safety and clinical effects of ultrasound-guided cervical medial branch blocks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neck Pain, Cervical Spondylosis
- What is being tested?
- Block
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2021to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to a tertiary outpatient pain clinic for diagnosis and treatment of chronic neck pain
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Bill Nelems Pain and Research Centre
Kelowna, British Columbia, V1Y 0G1
About this study
Official title: 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.
Read the 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.
- Conditions
- Neck Pain, Cervical Spondylosis
- Being tested
- Block
- Medical subject headings
- Neck Pain, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlockProcedure or surgery
cervical medial branch block
| Study group | Role | What they receive |
|---|---|---|
| Block | Patients undergoing ultrasound-guided cervical medial branch blocks as part of their usual care Receives: Procedure: Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 14 days after block
Secondary outcomes (6)
Patient reported pain
Lowest/highest/average pain score over last 7 days (NRS, 11-point scale)
Measured: Pre-block, then every 2 weeks for 3 months.
NDI
Neck disability index
Measured: Pre-block, then every 2 weeks for 3 months.
PHQ-9
Depression scale
Measured: Pre-block then at 1,2 and 3 months post block.
GAD-7
Anxiety scale
Measured: Pre-block then at 1,2 and 3 months post block.
PCS
Pain catastrophizing scale
Measured: Pre-block then at 1,2 and 3 months post block.
PGIC
Patient global impression of change 7-point scale
Measured: Pre-block, then every 2 weeks for 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start5 May 2021
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roderick Finlayson, University of British Columbia
- Investigators
- Roderick J Finlayson, MD, Principal investigator, University of British ColumbiaJohn-Paul B Etheridge, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852393
- Sponsor's protocol ID
- 2020-21-105-H
- Status last verified
- Nov 2023
- First submitted
- 12 Apr 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Aug 5;51(8):886-893. doi: 10.1136/rapm-2025-106457.
PubMed 40441772Etheridge 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.
PubMed 38508589
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Safety and Clinical Effects of Ultrasound-guided Cervical Medial Branch Blocks
- ClinicalTrials.gov ID
- NCT04852393
- Acronym / sponsor ID
- 2020-21-105-H
- Conditions
- Neck Pain, Cervical Spondylosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Montreal General HospitalUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Block | – | Procedure: BlockPatients undergoing ultrasound-guided cervical medial branch blocks as part of their usual care |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to a tertiary outpatient pain clinic for diagnosis and treatment of chronic neck pain
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blockcervical medial branch block | Procedure or surgery | Block |
Primary outcome
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)
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).
6 secondary outcomes
Patient reported pain
Time frame: Pre-block, then every 2 weeks for 3 months.
NDI
Time frame: Pre-block, then every 2 weeks for 3 months.
PHQ-9
Time frame: 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.
PCS
Time frame: Pre-block then at 1,2 and 3 months post block.
PGIC
Time frame: Pre-block, then every 2 weeks for 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 40441772Finlayson 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. 2026 Aug 5;51(8):886-893. doi: 10.1136/rapm-2025-106457.
- Derived from this study: PubMed 38508589Etheridge 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roderick J Finlayson, MD principal investigator
University of British Columbia
John-Paul B Etheridge, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Cervical Spondylosis, run by Montreal General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate complications (time frame: Immediately after block). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04852393, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.