Clinical trial NCT04852393: Ultrasound-guided Cervical Medial Branch Blocks
Official title: A Prospective Evaluation of the Safety and Clinical Effects of Ultrasound-guided Cervical Medial Branch Blocks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Cervical Spondylosis
Lead sponsor: Montreal General Hospital
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to a tertiary outpatient pain clinic for diagnosis and treatment of chronic neck pain

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Immediate complications
timeFrame: Immediately after block
measure: Delayed complications
timeFrame: 14 days after block
Secondary outcomes:
measure: Patient reported pain
timeFrame: Pre-block, then every 2 weeks for 3 months.
measure: NDI
timeFrame: Pre-block, then every 2 weeks for 3 months.
measure: PHQ-9
timeFrame: Pre-block then at 1,2 and 3 months post block.
measure: GAD-7
timeFrame: Pre-block then at 1,2 and 3 months post block.
measure: PCS
timeFrame: Pre-block then at 1,2 and 3 months post block.
measure: PGIC
timeFrame: Pre-block, then every 2 weeks for 3 months.
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Bill Nelems Pain and Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Roderick J Finlayson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: John-Paul B Etheridge, MD
role: PRINCIPAL_INVESTIGATOR
References: