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A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome (STU00097239)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Conventional radiofrequency ablation (RFA)
Cooled Radiofrequency Ablation (CRFA)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Lumbar Facet Syndrome

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with lumbar facet syndrome pain who would undergo treatment by lumbar medial branch radiofrequency ablation.
  • Low back pain for at least 6 months.
  • Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic care.
  • Pain diagram suggesting possibility of facet-mediated pain.
  • Referred pain when present not beyond the knee.
  • Positive response to at least 1 set of diagnostic intra-articular facet injections or medial branch blocks, defined as > 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).

Exclusion Criteria:

  • Focal neurologic signs or symptoms.
  • Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis.
  • Previous radiofrequency ablation treatment for similar symptoms.
  • Patient refusal.
  • Lack of consent.
  • Active systemic or local infections at the site of proposed needle and electrode placement.
  • Coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications.
  • Allergy to medications being used for injection procedures (contrast dye, local anesthetic, IV sedative).
  • Inability to read English, communicate with staff, or participate in follow up.
  • Pregnancy.
  • Cognitive deficit.
  • Negative response to diagnostic intra-articular facet injections or medial branch blocks, defined as < 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).
  • Daily opiate analgesic use more exceeding 3 months prior to study inclusion.
  • Unstable medical or psychiatric illness.

Sites / Locations

  • Anesthesiology Pain Managment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Conventional radiofrequency ablation (RFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.

Cooled radiofrequency ablation (CRFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.

Outcomes

Primary Outcome Measures

Pain improvement
Percent of participants who reported 50% or greater improvement in pain

Secondary Outcome Measures

Global pain score
Global Numeric Rating Scale (NRS, 0 is no pain and 10 is worst pain imaginable)
McGill Pain Questionnaire (MPQ)
Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).
Pain Anxiety Symptom Scale short form (PASS-20)
The PASS-20 assesses 4 factorially distinct components of pain-related anxiety. Each question is in a form of a 6-point Likert Scale anchored from 0 (never) to 5 (always).
Center for Epidemiologic Studies Depression short form index (CESD-10)
The possible range of the 10-item scale is 0 to 30, and a cut off score of ten or higher indicates the presence of significant depressive symptoms. Subjects responded to each item of the scale by rating the frequency of each mood or symptom ''during the past week'' on a four-point scale.

Full Information

First Posted
June 17, 2015
Last Updated
September 5, 2018
Sponsor
Northwestern University
Collaborators
American Pain Society
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1. Study Identification

Unique Protocol Identification Number
NCT02478437
Brief Title
A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome
Acronym
STU00097239
Official Title
A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for the Treatment of Lumbar Facet Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
American Pain Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the medial branch nerves of the lumbar facet joint is effective for the treatment of low back pain. CRFA blocks the nerves that carry pain signals from joints in the lower back such that the brain does not receive the message that the low back is in pain. This technique is commonly performed by burning these nerves rather freezing them, but it is suspected that freezing them results in better pain relief. The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back. We are performing this study in order to determine if that is the case.
Detailed Description
The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back. We are performing this study in order to determine if that is the case.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Lumbar Facet Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Conventional radiofrequency ablation (RFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Cooled radiofrequency ablation (CRFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.
Intervention Type
Procedure
Intervention Name(s)
Conventional radiofrequency ablation (RFA)
Intervention Description
A conventional RFA electrode with a 10mm active tip will be used. RFA lesions will be performed for 90 seconds with the maximum electrode temperature raised to 80°C.
Intervention Type
Procedure
Intervention Name(s)
Cooled Radiofrequency Ablation (CRFA)
Intervention Description
Following 18G C-RFA electrode positioning, 1cc of 2% lidocaine will be injected through the introducer needle for anesthesia during the ablation. The maximum electrode temperature is 60°C.
Primary Outcome Measure Information:
Title
Pain improvement
Description
Percent of participants who reported 50% or greater improvement in pain
Time Frame
6 months post-procedure
Secondary Outcome Measure Information:
Title
Global pain score
Description
Global Numeric Rating Scale (NRS, 0 is no pain and 10 is worst pain imaginable)
Time Frame
1 month, 3 months, 6 months and 12 months post procedure
Title
McGill Pain Questionnaire (MPQ)
Description
Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).
Time Frame
1 month, 3 months, 6 months and 12 months post procedure
Title
Pain Anxiety Symptom Scale short form (PASS-20)
Description
The PASS-20 assesses 4 factorially distinct components of pain-related anxiety. Each question is in a form of a 6-point Likert Scale anchored from 0 (never) to 5 (always).
Time Frame
1 month, 3 months, 6 months and 12 months post procedure
Title
Center for Epidemiologic Studies Depression short form index (CESD-10)
Description
The possible range of the 10-item scale is 0 to 30, and a cut off score of ten or higher indicates the presence of significant depressive symptoms. Subjects responded to each item of the scale by rating the frequency of each mood or symptom ''during the past week'' on a four-point scale.
Time Frame
1 month, 3 months, 6 months and 12 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with lumbar facet syndrome pain who would undergo treatment by lumbar medial branch radiofrequency ablation. Low back pain for at least 6 months. Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic care. Pain diagram suggesting possibility of facet-mediated pain. Referred pain when present not beyond the knee. Positive response to at least 1 set of diagnostic intra-articular facet injections or medial branch blocks, defined as > 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine). Exclusion Criteria: Focal neurologic signs or symptoms. Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis. Previous radiofrequency ablation treatment for similar symptoms. Patient refusal. Lack of consent. Active systemic or local infections at the site of proposed needle and electrode placement. Coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications. Allergy to medications being used for injection procedures (contrast dye, local anesthetic, IV sedative). Inability to read English, communicate with staff, or participate in follow up. Pregnancy. Cognitive deficit. Negative response to diagnostic intra-articular facet injections or medial branch blocks, defined as < 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine). Daily opiate analgesic use more exceeding 3 months prior to study inclusion. Unstable medical or psychiatric illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Walega, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology Pain Managment Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30777903
Citation
McCormick ZL, Choi H, Reddy R, Syed RH, Bhave M, Kendall MC, Khan D, Nagpal G, Teramoto M, Walega DR. Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint pain. Reg Anesth Pain Med. 2019 Mar;44(3):389-397. doi: 10.1136/rapm-2018-000035.
Results Reference
derived

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A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome

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