Skip to main content
OpenTrials
Completed

NCT Number: NCT04852393

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neck Pain Bone Diseases Cervical Spondylosis Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bill Nelems Pain and Research Centre

Kelowna, British Columbia, V1Y 0G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

block

Procedure

cervical medial branch block

Primary outcomes

  1. 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)

  2. 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).

Secondary outcomes

  1. 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)

  2. NDI

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

    Neck disability index

  3. PHQ-9

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

    Depression scale

  4. GAD-7

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

    Anxiety scale

  5. PCS

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

    Pain catastrophizing scale

  6. PGIC

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

    Patient global impression of change 7-point scale

Sponsors and collaborators

Lead sponsor

Montreal General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.