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

A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for the Treatment of Lumbar Facet Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Conventional radiofrequency ablation (RFA); Procedure: Cooled Radiofrequency Ablation (CRFA)

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Anesthesiology Pain Managment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Conventional radiofrequency ablation (RFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.	Procedure: Conventional radiofrequency ablation (RFA); 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.
Active Comparator: Group 2; Cooled radiofrequency ablation (CRFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.	Procedure: Cooled Radiofrequency Ablation (CRFA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain improvement	Percent of participants who reported 50% or greater improvement in pain	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global pain score	Global Numeric Rating Scale (NRS, 0 is no pain and 10 is worst pain imaginable)	1 month, 3 months, 6 months and 12 months post procedure
McGill Pain Questionnaire (MPQ)	Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).	1 month, 3 months, 6 months and 12 months post procedure
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).	1 month, 3 months, 6 months and 12 months post procedure
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.	1 month, 3 months, 6 months and 12 months post procedure

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: American Pain Society

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Lumbar Facet Syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: STU00097239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO