Back to resultsEnd-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves (EndPaRL)
Primary Purpose
Neck Pain, Zygapophyseal Joint Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning
Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Radiofrequency neurotomy, Cervical Medial Branch Nerves
Eligibility Criteria
Inclusion Criteria: Adult patient of either gender aged 18-85 years Predominant axial (non-radicular) neck pain for at least 3 months 7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation Moderate or greater functional impairment due to pain, defined as NDI Questionnaire raw score of 15 out of 50 (≥30% Cervical spine imaging compatible with Pathria's grade 3 or grade 4 zygapophyseal joint osteoarthritis Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months; Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic Exclusion Criteria: Participants with financial incentives or litigation associated with ongoing pain Inability to complete assessment instruments Chronic widespread pain Prior RFN of the CMBN; Severe mental health issues Pregnancy or other reason that precludes the use of fluoroscopy Untreated coagulopathy Systemic or local infection at the time of screening.
Sites / Locations
- University Health Network (UHN)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RFN of CMBNn with end-on lesioning with multitIned trident cannulae
RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)
Arm Description
Intervention type: RF nerve end-on lesioning at 80-850 Celsius for 90 seconds Intervention name: End-on placement of the multitined trident cannulae Intervention description: Patient in lateral position, targeting joint position between the inferior C2 and superior C3 facets, the middle of the facet pillars for the third to fifth cervical levels, and the superior part of the sixth and seventh cervical facets
Intervention type: RF nerve parallel lesioning at 80-850 Celsius for 90 seconds Intervention name: Straight sharp conventional (SIS's technique) Intervention description: Technique as described in the SIS Practice Guidelines for parallel lesioning cannulae placement
Outcomes
Primary Outcome Measures
Difference in mean Numerical Rating Scale (NRS) for pain scores
Difference in the mean pain scores before and after procedure. Scale from 0 to 10, where higher scores mean worse outcome
Proportion of patients with positive analgesic response
Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline)
Secondary Outcome Measures
Difference in the mean Numerical Rating Scale (NRS) for pain scores
Difference in mean NRS for pain scores at 6 and 12 months after the RFA procedure. Scale from 0 to 10, where higher scores mean worse outcome
Proportion of patients with positive analgesic response
Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline) at 6 & 12 months
Proportion of patients with reduction in the Neck Disability Index (NDI) score
Proportion of patients with ≥10% reduction in the NDI score at 3, 6, and 12 months. Scale from 0 to 50, where higher scores mean worse outcome
Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale
PGIC score is a 7 point scale depicting a patient's subjective rating of overall improvement over time, as proportion of participants reporting improvement in the PGIC scale at 3, 6, and 12 months
Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality
Difference in mean PSQI scores scores at 3, 6, and 12 months. It has a range of 0-21; higher scores indicate worse sleep quality.
Difference in mean European Quality of Life (EQ-5D-5L score), a self-assessed, health related, quality of life questionnaire. It ranges from 5 to 25, where higher scores indicate worse outcome.
Difference in mean EQ-5D-5L scores at 3, 6, and 12 months
Differences in duration of procedure between 2 groups
Differences in duration of procedure in two groups
Differences in discomfort procedure between 2 groups
Differences in patient discomfort of procedure
Differences in radiation dose of procedure between 2 groups
Differences in radiation dose of procedure
Differences in cost of procedure between 2 groups
Differences in cost of the procedures
Difference in opioid requirements in daily oral morphine equivalents between the groups
Difference in opioid requirements in daily oral morphine equivalents in mg averaged over the 1 week before and at 3, 6, and 12 months follow-ups after the procedure
Full Information
NCT ID
NCT05818774
First Posted
April 5, 2023
Last Updated
April 18, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05818774
Brief Title
End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves
Acronym
EndPaRL
Official Title
A Prospective, Randomized, Double Blind Clinical Trial Comparing End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves: The EndPaRL Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of the EndPaRL study is to compare the efficacy and effectiveness of the two techniques utilizing sharp straight conventional radiofrequency needle with a trident needle for radiofrequency neurotomy of Cervical Medial Branch Nerves (CMBNs), in patients presenting with chronic, moderate-to-severe, neck pain due to cervical zygapophyseal joint osteoarthritis, as diagnosed by positive responses to two consecutive diagnostic blocks with local anesthetic of the CMBN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Zygapophyseal Joint Arthritis
Keywords
Radiofrequency neurotomy, Cervical Medial Branch Nerves
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RFN of CMBNn with end-on lesioning with multitIned trident cannulae
Arm Type
Experimental
Arm Description
Intervention type: RF nerve end-on lesioning at 80-850 Celsius for 90 seconds
Intervention name: End-on placement of the multitined trident cannulae
Intervention description:
Patient in lateral position, targeting joint position between the inferior C2 and superior C3 facets, the middle of the facet pillars for the third to fifth cervical levels, and the superior part of the sixth and seventh cervical facets
Arm Title
RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique)
Arm Type
Active Comparator
Arm Description
Intervention type: RF nerve parallel lesioning at 80-850 Celsius for 90 seconds
Intervention name: Straight sharp conventional (SIS's technique)
Intervention description:
Technique as described in the SIS Practice Guidelines for parallel lesioning cannulae placement
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning
Intervention Description
Intervention type: RF nerve lesioning at 80-85 degree Celsius for 90 seconds Intervention name: Straight sharp conventional (SIS's technique)
Intervention description:
Technique as described in the SIS Practice Guidelines for parallel lesioning cannulae placement
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae
Intervention Description
Intervention type: RF nerve lesioning lesioning at 80-850 Celsius for 90 seconds Intervention name: End-on placement of the multitined trident cannulae
Intervention description:
Patient in lateral position, targeting joint position between the inferior C2 and superior C3 facets, the middle of the facet pillars for the third to fifth cervical levels, and the superior part of the sixth and seventh cervical facets.
Primary Outcome Measure Information:
Title
Difference in mean Numerical Rating Scale (NRS) for pain scores
Description
Difference in the mean pain scores before and after procedure. Scale from 0 to 10, where higher scores mean worse outcome
Time Frame
3 months
Title
Proportion of patients with positive analgesic response
Description
Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Difference in the mean Numerical Rating Scale (NRS) for pain scores
Description
Difference in mean NRS for pain scores at 6 and 12 months after the RFA procedure. Scale from 0 to 10, where higher scores mean worse outcome
Time Frame
at 6 and 12 months
Title
Proportion of patients with positive analgesic response
Description
Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline) at 6 & 12 months
Time Frame
at 6 and 12 months
Title
Proportion of patients with reduction in the Neck Disability Index (NDI) score
Description
Proportion of patients with ≥10% reduction in the NDI score at 3, 6, and 12 months. Scale from 0 to 50, where higher scores mean worse outcome
Time Frame
at 3, 6, and 12 months
Title
Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale
Description
PGIC score is a 7 point scale depicting a patient's subjective rating of overall improvement over time, as proportion of participants reporting improvement in the PGIC scale at 3, 6, and 12 months
Time Frame
at 3, 6, and 12 months
Title
Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality
Description
Difference in mean PSQI scores scores at 3, 6, and 12 months. It has a range of 0-21; higher scores indicate worse sleep quality.
Time Frame
at 3, 6, and 12 months
Title
Difference in mean European Quality of Life (EQ-5D-5L score), a self-assessed, health related, quality of life questionnaire. It ranges from 5 to 25, where higher scores indicate worse outcome.
Description
Difference in mean EQ-5D-5L scores at 3, 6, and 12 months
Time Frame
at 3, 6, and 12 months
Title
Differences in duration of procedure between 2 groups
Description
Differences in duration of procedure in two groups
Time Frame
day of procedure
Title
Differences in discomfort procedure between 2 groups
Description
Differences in patient discomfort of procedure
Time Frame
day of procedure
Title
Differences in radiation dose of procedure between 2 groups
Description
Differences in radiation dose of procedure
Time Frame
day of procedure
Title
Differences in cost of procedure between 2 groups
Description
Differences in cost of the procedures
Time Frame
day of procedure
Title
Difference in opioid requirements in daily oral morphine equivalents between the groups
Description
Difference in opioid requirements in daily oral morphine equivalents in mg averaged over the 1 week before and at 3, 6, and 12 months follow-ups after the procedure
Time Frame
at 3, 6, and 12 months follow-ups after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient of either gender aged 18-85 years
Predominant axial (non-radicular) neck pain for at least 3 months
7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation
Moderate or greater functional impairment due to pain, defined as NDI Questionnaire raw score of 15 out of 50 (≥30%
Cervical spine imaging compatible with Pathria's grade 3 or grade 4 zygapophyseal joint osteoarthritis
Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months;
Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic
Exclusion Criteria:
Participants with financial incentives or litigation associated with ongoing pain
Inability to complete assessment instruments
Chronic widespread pain
Prior RFN of the CMBN;
Severe mental health issues
Pregnancy or other reason that precludes the use of fluoroscopy
Untreated coagulopathy
Systemic or local infection at the time of screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kawal Singh
Phone
(416) 603-5800
Ext
3959
Email
kawalpreet.singh@uhnresearch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuj Bhatia, MD, PhD
Organizational Affiliation
Department of Anesthesia and Pain Management, University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network (UHN)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kawal Singh
Phone
4166035118
Ext
3959
Email
kawalpreet.singh@uhnresearch.ca
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share the IPD at the moment
Citations:
PubMed Identifier
22458772
Citation
MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28.
Results Reference
background
PubMed Identifier
8929263
Citation
Lord SM, Barnsley L, Wallis BJ, McDonald GJ, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996 Dec 5;335(23):1721-6. doi: 10.1056/NEJM199612053352302.
Results Reference
result
PubMed Identifier
16083457
Citation
Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series of consecutive patients. Pain Med. 2005 Jul-Aug;6(4):282-6. doi: 10.1111/j.1526-4637.2005.00047.x.
Results Reference
result
Learn more about this trial
End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves
We'll reach out to this number within 24 hrs