Neck Pain Clinical Trial
Official title:
A Prospective Evaluation of the Safety and Clinical Effects of Ultrasound-guided Cervical Medial Branch Blocks
NCT number | NCT04852393 |
Other study ID # | 2020-21-105-H |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 5, 2021 |
Est. completion date | October 1, 2023 |
Verified date | November 2023 |
Source | Montreal General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In this study we will prospectively examine the safety and clinical effects of ultrasound-guided cervical medial branch blocks.
Status | Completed |
Enrollment | 500 |
Est. completion date | October 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Bill Nelems Pain and Research Centre | Kelowna | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Montreal General Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Patient reported pain | Lowest/highest/average pain score over last 7 days (NRS, 11-point scale) | Pre-block, then every 2 weeks for 3 months. | |
Secondary | NDI | Neck disability index | Pre-block, then every 2 weeks for 3 months. | |
Secondary | PHQ-9 | Depression scale | Pre-block then at 1,2 and 3 months post block. | |
Secondary | GAD-7 | Anxiety scale | Pre-block then at 1,2 and 3 months post block. | |
Secondary | PCS | Pain catastrophizing scale | Pre-block then at 1,2 and 3 months post block. | |
Secondary | PGIC | Patient global impression of change 7-point scale | Pre-block, then every 2 weeks for 3 months. |
Status | Clinical Trial | Phase | |
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Completed |
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