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Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

Primary Purpose

Back Pain Without Radiation, Low Back Pain, Lumbar Radiofrequency Neurotomy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parallel placement of 16 gauge electrodes
Perpendicular placement with 22 gauge electrodes
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Without Radiation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged > 40, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
  • unilateral or bilateral low back pain of at least 4/10 on Numeric Pain Rating Scale (NPRS) present for at least 2 months that has failed to adequately respond to at least 6 weeks of physical therapy and oral pain medication
  • at least 80% improvement on two consecutive lumbar medial branch blocks of no more than a total of 4 lumbar facet joints
  • beyond the above stated criteria, the decision to initiate the process of a first medial branch block is based on clinical decision making of the treating physician
  • Patient consents to treatment in a shared decision-making process with the treating physician.

Exclusion Criteria:

  • Those whose primary complain is lumbar radiculopathy
  • Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
  • Those involved in active litigation relevant to their pain.
  • Those unable to read English and complete the assessment instruments.
  • Those unable to attend follow up appointments
  • The patient is incarcerated.
  • History of prior lumbar fusion
  • Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy
  • History of lumbar steroid injection (epidural steroid injection, sacroiliac joint steroid injection, lumbar facet steroid injection) within the prior 3 months.
  • Possible pregnancy or other reason that precludes the use of fluoroscopy.
  • Allergy to contrast media or local anesthetics.
  • BMI>40.
  • Active Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
  • Active infection or treatment of infection with antibiotics within the past 7 days.
  • Medical conditions causing significant functional disability (e.g., stroke, COPD)
  • Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
  • Addictive behavior, severe clinical depression, or psychotic features.

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Parallel placement of 16 gauge electrodes

Perpendicular placement with 22 gauge electrodes

Arm Description

Parallel Group will undergo radiofrequency ablation via the approach described in Spine Intervention Practice Guidelines via 16 gauge electrodes. Specifically, the target nerve will be targeted with a parallel approach so as the electrode lay parallel to the nerves location within the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.

Perpendicular Group will undergo radiofrequency ablation via the approach described in Spine Intervention Society Practice Guidelines for medial branch blocks, using a 22 gauge electrode. Specifically, the target nerve will be targeted with a perpendicular approach so as the tip of electrode contact the nerve at some point of it course along the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.

Outcomes

Primary Outcome Measures

Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change
Global Impression of Change; Range 0-7 0 = Very much improved 7 = Very much worse
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Numeric Rating Scale of Pain Intensity
Numeric Rating Scale of Pain Intensity; Range 0-10 0 = No pain 10 = Pain as bad as you can imagine
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Pain
Pain sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = No Pain 10 = Pain as bad as you can image
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Enjoyment
Enjoyment sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), General Activity
General Activity sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Not Requiring Other Healthcare
Categorical Outcome; ideal would be that patients no longer require other care for the condition for which they were treated. So, the scoring is simply absolute. The instrument is neither designed nor intended for more granular analysis, on the grounds that partial reduction in doses required, but nevertheless continuation of other treatment, falls short of indicating a worthwhile, successful outcome (PubMed Identifier: 25312899).
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Returning to Work
Categorical outcome; it is very relevant if return to work is achieved. Failure to return to work is too vexatious an issue, with so many determinants that it is neither efficient nor effective to bother trying to record them (Reference PMID: 25312899).
Change in Oswestry Disability Index (ODI)
The questionnaire is designed to give information on how pain is affecting the ability to manage everyday life. The range of scores is 0-100%. 0-20%: "minimal disability": The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21-40%: "moderate disability": The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41-60%: "severe disability": Pain remains the main problem in this group but activities of daily living are affected. 61-80%: "crippled": Back pain impinges on all aspects of the patient's life. 81-100%: These patients are either bed-bound or exaggerating their symptoms.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2019
Last Updated
February 28, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
Spine Intervention Society
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1. Study Identification

Unique Protocol Identification Number
NCT03912519
Brief Title
Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy
Official Title
Randomized Trial Comparing Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Spine Intervention Society

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
Low back pain is a leading cause of disability worldwide. The lumbar zygapophyseal joints (z-joints) are estimated to be the source of low back pain between 10% and 40% of the time. Observational studies have shown that lumbar medial branch radiofrequency neurotomy (LMBRFN) can be an effective treatment for z-joint low back pain. Nonetheless, other publications such as the Cochrane collaboration systematic review and the "Minimal Interventional Treatments for Participants with Chronic Low Back Pain" or "MINT" randomized controlled trial conclude that LMBRFN is not efficacious. These discrepancies in the literature may be due to differences in patient selection and procedural technique. This study aims to employ patient selection via dual medial branch block resulting in at least 80% relief on both occasions. Using this rather strict enrollment criteria, the aim of the study is to then compare LMBRFN utilizing 16 gauge needles via the "parallel" approach as endorsed by Spine Intervention Society guidelines to LMBRFN performed with 22 gauge needles and another commonly employed "perpendicular" technique similar to that approach used for medial branch blocks. The primary outcome of the study will be to determine if there is a difference in the percentage of patients with lumbar facet pain who achieve moderate or good response (improvement of Numeric Pain Rating Scale of at least 50% or 80%) or in the duration of effect (median duration of moderate or good response in those with positive outcome) between these two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Without Radiation, Low Back Pain, Lumbar Radiofrequency Neurotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parallel placement of 16 gauge electrodes
Arm Type
Active Comparator
Arm Description
Parallel Group will undergo radiofrequency ablation via the approach described in Spine Intervention Practice Guidelines via 16 gauge electrodes. Specifically, the target nerve will be targeted with a parallel approach so as the electrode lay parallel to the nerves location within the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.
Arm Title
Perpendicular placement with 22 gauge electrodes
Arm Type
Active Comparator
Arm Description
Perpendicular Group will undergo radiofrequency ablation via the approach described in Spine Intervention Society Practice Guidelines for medial branch blocks, using a 22 gauge electrode. Specifically, the target nerve will be targeted with a perpendicular approach so as the tip of electrode contact the nerve at some point of it course along the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.
Intervention Type
Procedure
Intervention Name(s)
Parallel placement of 16 gauge electrodes
Intervention Description
Parallel technique
Intervention Type
Procedure
Intervention Name(s)
Perpendicular placement with 22 gauge electrodes
Intervention Description
Perpendicular technique
Primary Outcome Measure Information:
Title
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change
Description
Global Impression of Change; Range 0-7 0 = Very much improved 7 = Very much worse
Time Frame
Baseline to 12 months
Title
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Numeric Rating Scale of Pain Intensity
Description
Numeric Rating Scale of Pain Intensity; Range 0-10 0 = No pain 10 = Pain as bad as you can imagine
Time Frame
Baseline to 12 months
Title
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Pain
Description
Pain sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = No Pain 10 = Pain as bad as you can image
Time Frame
Baseline to 12 months
Title
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Enjoyment
Description
Enjoyment sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes
Time Frame
Baseline to 12 months
Title
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), General Activity
Description
General Activity sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes
Time Frame
Baseline to 12 months
Title
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Not Requiring Other Healthcare
Description
Categorical Outcome; ideal would be that patients no longer require other care for the condition for which they were treated. So, the scoring is simply absolute. The instrument is neither designed nor intended for more granular analysis, on the grounds that partial reduction in doses required, but nevertheless continuation of other treatment, falls short of indicating a worthwhile, successful outcome (PubMed Identifier: 25312899).
Time Frame
Baseline to 12 months
Title
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Returning to Work
Description
Categorical outcome; it is very relevant if return to work is achieved. Failure to return to work is too vexatious an issue, with so many determinants that it is neither efficient nor effective to bother trying to record them (Reference PMID: 25312899).
Time Frame
Baseline to 12 months
Title
Change in Oswestry Disability Index (ODI)
Description
The questionnaire is designed to give information on how pain is affecting the ability to manage everyday life. The range of scores is 0-100%. 0-20%: "minimal disability": The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21-40%: "moderate disability": The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41-60%: "severe disability": Pain remains the main problem in this group but activities of daily living are affected. 61-80%: "crippled": Back pain impinges on all aspects of the patient's life. 81-100%: These patients are either bed-bound or exaggerating their symptoms.
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged > 40, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits unilateral or bilateral low back pain of at least 4/10 on Numeric Pain Rating Scale (NPRS) present for at least 2 months that has failed to adequately respond to at least 6 weeks of physical therapy and oral pain medication at least 80% improvement on two consecutive lumbar medial branch blocks of no more than a total of 4 lumbar facet joints beyond the above stated criteria, the decision to initiate the process of a first medial branch block is based on clinical decision making of the treating physician Patient consents to treatment in a shared decision-making process with the treating physician. Exclusion Criteria: Those whose primary complain is lumbar radiculopathy Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation). Those involved in active litigation relevant to their pain. Those unable to read English and complete the assessment instruments. Those unable to attend follow up appointments The patient is incarcerated. History of prior lumbar fusion Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy History of lumbar steroid injection (epidural steroid injection, sacroiliac joint steroid injection, lumbar facet steroid injection) within the prior 3 months. Possible pregnancy or other reason that precludes the use of fluoroscopy. Allergy to contrast media or local anesthetics. BMI>40. Active Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus). Active infection or treatment of infection with antibiotics within the past 7 days. Medical conditions causing significant functional disability (e.g., stroke, COPD) Chronic widespread pain or somatoform disorder (e.g. fibromyalgia). Addictive behavior, severe clinical depression, or psychotic features.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byron Schneider, MD
Phone
615-322-0738
Email
byron.j.schneider@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Blake Fechtel, MD MSc
Phone
703-647-0143
Email
fechtel.blake@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron Schneider, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blake Fechtel, MD MSc
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byron Schneider, MD
Phone
615-322-0738
Email
byron.j.schneider@vumc.org
First Name & Middle Initial & Last Name & Degree
Blake Fechtel, MD MSc
Phone
703-647-0143
Email
fechtel.blake@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

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